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Devices and Radiological Health

<< Return to FY 2007 Budget Summary

 

  FY 2005
Actual
FY 2006
Enacted 1/
FY 2007
Estimate
Increase or
Decrease
Program Level $244,282,000 $260,503,000 $271,571,000 11,068,000
Center
$183,157,000
$192,714,000
$200,480,000
7,766,000
FTE
1,104
1,136
1,158
22
Field
$61,125,000
$67,789,000
$71,091,000
3,302,000
FTE
412
407
421
14
Program Level FTE 1,516 1,543 1,579 36
Budget Authority $214,962,000 $220,564,000 $229,334,000 8,770,000
Trigger Needs for ADUFA and MDUFMA
 
 
$4,950,000 $4,950,000
FTE
 
 
28 28
Cost of Living
 
 
$3,334,000 $3,334,000
Strategic Redeployment
 
 
$486,000 $486,000
FTE
 
 
0 0
Budget Authority FTE 1,367 1,378 1,406 28
User Fees $29,320,000 $39,939,000 $42,237,000 $16,864,000
MDUFMA $16,361,000 $22,978,000 $24,931,000 $1,953,000
FTE
115
131
139
8
MQSA
$12,959,000
$16,961,000
$17,306,000
$345,000
FTE
34
34
34
0
User Fee FTE 149 165 173 8

1/Includes a one percent rescission

 

 Historical Funding and FTE Levels
Fiscal Year Program Level Budget Authority User Fees Program Level FTE
2003 Actual 217,285,000 193,350,000 23,935,000 1,485
2004 Actual $221,506,000 $191,143,000 $30,363,000 1,515
2005 Actual $244,282,000 $214,962,000 $29,320,000 1,516
2006 Enacted $260,503,000 $220,564,000 $39,939,000 1,543
2007 Estimate $271,571,000 $229,334,000 $42,237,000 1,579

 

Statement of Budget Request

 

The Center for Devices and Radiological Health is requesting $271,571,000 in program level resources for accomplishing its mission activities including:

  • Promoting and protecting the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.
  • Meeting all statutory responsibilities for review of new medical devices.
  • Assuring medical product safety by monitoring the use of all medical devices, and the function and use of radiological health.
  • Managing emerging hazards to prevent widespread health and safety threats and ensure safe and effective new technologies.
  • Applying the Total Product Life Cycle model across the range of Devices and Radiological Health activities, by covering products from concept to obsolescence.
  • Connecting to the global public health community, and partner with stakeholders.
  • Using science in the regulatory process to the maximum extent.
  • Attracting and retaining a diverse and high quality workforce.
  • Measuring and setting targets to maximize the program's impact on public health.

 

Program Description

 

CDRH regulates a wide array of medical devices, from: artificial hearts, pacemakers, drug-coated stents to deep brain stimulators and spinal implants, mammography and dialysis machines and infusion pumps to intraocular lenses and cochlear implants; as well as robotic surgery devices, stair-climbing wheelchairs, in vitro diagnostic devices, radiologic devices and many others. To keep pace with the rapid development of new technology, and to make decisions based on the best scientific information and knowledge available, CDRH routinely consults with experts in the academic community, other government entities, clinical practice, and the military. CDRH also supports initiatives to improve the Nation's ability to respond to bioterrorism and public health challenges, including expediting the review of bioterrorism diagnostics, managing product shortages, supporting safe and effective development and use of battlefield and emergency devices, ensuring safe use of x-ray machines in airports and other security systems, and assessing radiation products for misuse as weapons.

ORA supports CDRH by conducting preapproval inspections of both foreign and domestic establishments and other premarket-related activities such as: bioresearch monitoring of clinical research, preapproval inspections and laboratory method validations needed for premarket application decisions, and inspections of manufacturing facilities to determine if the factory is able to manufacture the product to the specifications stated in the application. ORA conducts risk-based domestic and foreign postmarket inspections, field exams and sampling of medical device manufacturers to assess their compliance with Good Manufacturing Practice requirements, and conducts inspections of reprocessors of single-use devices and radiological health products.To complement the regular field force, the Office of Criminal Investigations investigates instances of criminal activity in FDA regulated industries.

 

Performance Analysis

 

During the latest performance period, (FY 2005), the Medical Devices program met four of its seven center performance targets; expects to meet the remaining three when the data becomes available in June FY 2007; and met all three of its field performance targets.For more information about these performance goals and results, please see the Performance Detail section.

The Food & Drug Administration Modernization Act of 1997 gives FDA the mandate to replace universal user facility reporting with the Medical Product Surveillance Network (MedSun) that is composed of user facilities that constitute a representative profile of user reports.  FDA estimates that there may be as many as 300,000 injuries and deaths annually associated with device use and misuse. FDA surpassed by 200% our long-term goal of expanding patient surveillance by 50% by 2008, through increasing the number of patients covered from 17 million to 53 million this year. This will allow for more rapid identification and analysis of adverse events.  MedSun is a critical component towards achieving this long-term goal.

Performance Highlight:

FY 2007 Goal Target FY 2005 Results Context
Expand actively participating sites in Medsun Network to 76 percent. FDA recruited, trained and have functioning 354 facilities for the network MedSun will reduce device-related medical errors; serve as an advanced warning system; and create a two-way communication channel between FDA and the user-facility community.

 

Program Resource Changes

 

Budget Authority

Cost of Living-Pay: + $3,334,000

FDA's request for inflationary pay costs is essential to accomplishing our public health mission.Payroll costs account for more than sixty-percent of the FDA budget, and the Agency is not able to absorb this level of inflation on such a significant portion of its resources. The increase will allow FDA to maintain staffing levels, including a national cadre of specially trained scientific staff. The total estimate for pay increases is $20,267,000. The Devices portion of this increase is $3,334,000. These resources are vitally important for FDA to fulfill its mission to protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use.

Appropriated User Fee Trigger Needs — Maintaining Medical Device Review Programs:+ $ 4,950,000 and + 28 FTE

To meet the statutory requirements for collecting Medical Device User Fees, FDA must spend a minimum amount of appropriated resources, indexed to the cost of living, on the review process. If the appropriation and/or spending do not meet these minimum requirements (known as user fee triggers), the agency is unable to receive the supplemental user fee funding and the program terminates. The additional budget authority is needed to ensure that the trigger requirements are met. The requested amount for the Medical Device review Program is $4,950,000 and 28 FTE. The portion for the Center for Devices and Radiological Health is $2,901,000 and 15 FTE, and the portion for the Office of Regulatory Affairs is $2,049,000 million and 13 FTE.

 

User Fees

Medical Devices User Fee and Modernization Act:+$1,953,000 and + 7 FTE

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges. MDUFMA was signed into law October 26, 2002 and was amended by the Medical Device User Fee Stabilization Act of 2005. MDUFMA has three particularly significant provisions. These provisions allow for the collection of user fees for premarket applications, allow establishment inspections to be conducted by third parties and place new regulatory requirements on reprocessed single use devices. The revenues from these fees, and the appropriated trigger amounts will allow FDA to pursue a set of ambitious performance goals that will provide patients earlier access to safe and effective technology, and will provide more interactive and rapid review to the medical device industry. In FY 2007 FDA will work with Congress on the reauthorization of the Medical Device User Fee and Modernization Act. This increase of $1,953,000 will cover inflationary costs, as well as overhead and rent costs, for additional staff associated with the Act.

Mammography Quality Standards Act (MQSA):+$345,000

Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among American women. Experts estimate that one in eight American women will contract breast cancer during their lifetime. The MQSA, which was reauthorized in October 2004, addresses the public health need for safe and reliable mammography. The Act required that mammography facilities be certified by October 1994, and inspected annually to ensure compliance with national quality and safety standards. The reauthorization codified existing certification practices for mammography facilities and laid the groundwork for further study of key issues that include ways to improve physicians' ability to read mammograms and ways to recruit and retain skilled professionals to provide quality mammograms. The increase of $345,000 will cover inflation.

Proposed User Fees (Reclassified as Mandatory): (Non-Add)

Reinspection User Fee (Mandatory):+ $2,616,000 and + 22 FTE (Non-Add)

The Administration is proposing authorizing legislation that requires establishments to pay the full costs of reinspections and associated follow-up work when FDA reinspects facilities due to failure to meet Good Manufacturing Practices (GMPs) or other important FDA requirements.Under this proposal, these activities will be reclassified as mandatory user fees in FY 2007. FDA currently funds this activity through discretionary appropriations. Imposing a fee would generate $22.0 million in revenue, an estimated amount sufficient to fund the FY 2007 reinspections. The Devices Program component of this user fee is $2,616,000 and 22 FTE.

 

Justification of Base

 

FDA Strategic Goal: Enhancing Patient and Consumer Protection and Empowering Them with Better Information about Regulated Products

 

FDA will continue to improve problem detection and the timeliness of risk management actions aimed at preventing harm from regulated products, and will continue its highly-regarded risk communications activities aimed at increasing safe and effective use of medical products. FDA plans to:

 

Modernize Medicare and Medicaid through Safe Product Use

  • Expand the Home Health Care Initiative. This initiative addresses the growing trend of using clinical medical devices in the home setting and advances home health care opportunities. It does this by providing health care practitioners, consumers, and patients with internet-accessible information on the safe and effective operation of devices. Many of these devices were never intended to be used outside the hospital or by lay users. There will be a repository of devices specifically labeled for home use, brochures, references and hyperlinks to other government and private agencies working on home care issues.

 

Improve Problem Detection and Risk Management to Transform Health Care

  • Strengthen the Medical Product Surveillance Network (MedSun). This will be accomplished by increasing by five percent the number of sites sending in device problem reports to the program and recruiting new facilities to replace those that leave the network.This internet-based program is designed to reduce device-related medical errors by disseminating safety information. MedSun also serves as an advance warning system and creates an interactive communication channel between FDA and its system participants.
  • Pilot the use of "sub-networks" within MedSun, including hospital laboratories, pediatric ICUs, and catheterization and electrophysiology laboratories. This will allow us to more rapidly evaluate adverse events when they arise.
  • Receive process and review an estimated 200,000 medical device adverse event reports. Continue to develop an electronic adverse event repository system to accommodate electronic data entry and processing of adverse events for medical devices. This system will facilitate the review, analysis and management of the reports received each year. It will permit more efficient use of FDA analyst resources. It will provide FDA, health care professionals and consumers, and other state and Federal agencies with the information necessary to make faster and more thorough risk management decisions.
  • Refine the Alternative Summary Reporting program to ease industry's reporting burden for device-based adverse events. By submitting the reports less frequently and in an abbreviated form, industry is relieved of the individual reporting burden. Yet the Agency can continue to monitor these adverse events on an aggregate basis.
  • Provide guidance to industry on the recommended contents of annual reports for premarket approval (PMA) devices. These reports will allow FDA to monitor yearly trends in adverse events and device malfunctions.
  • Improve the feedback of post-approval data to premarket reviewers in order to improve the quality and timeliness of premarket reviews.
  • Use and improve postmarket communication to mitigate risk from medical device problems. this has been done through:
    • Public health notifications about Ralstonia bacterial contamination of a humidifier used in newborns.
    • Recommendations for clinicians concerning the recalled Enterex implantable device for Gastroesaphogeal Reflux Disease (GERD), information regarding failures with the Guidant Implantable Cardioverter Defibrillator.
    • Recommendations to avoid entrapment of vulnerable patients in the Vail bed.
  • Incorporate human factors risk analysis in premarket and postmarket decision-making. This will enhance the identification of risks associated with the use of medical products and to reduce the occurrence of adverse events related to use error.

 

Communicating Risks More Effectively to Empower Consumers

  • Continue publishing the "FDA & You" electronic newsletter that reaches the secondary schools and health education populations with timely health news.  This ongoing collaboration between the FDA Centers is published three times a year.
  • Maintain the newly-launched "Maturity Health Matters" online newsletter geared to providing FDA regulated product information of interest to the older adult population. This newsletter will publish three times a year. It will focus on FDA regulated products that help people live longer more productive lives. The inaugural issue primarily addressed medical devices; future issues will include collaboration with all FDA Centers.
  • Maintain technical distribution capabilities to allow the content of "FDA Patient Safety News" (PSN) to be readily available as a teaching tool. FDA PSN is an Agency-wide monthly television news show that brings vital information on how to improve the safety of drugs, devices, vaccines, and diagnostic products to physicians, nurses, pharmacists, risk managers and educators across the nation.
  • Maintain consumer websites. These provide current and reliable information on issues like cardiovascular disease, pediatric medical devices, radiation emitting electronic products, whole body scanning, personal protective equipment, cosmetic contact lenses, and phakic intraocular lenses-a newly approved, first-of-a-kind device.
  • Disseminate public health messages related to medical and diagnostic device use before, during, and after emergencies and natural disasters.
  • Maintain the redesigned Medical Device Recall website that provides a web-friendly, plain language overview of medical device recalls. The website now explains the various classes of medical device recalls and the procedures that FDA and companies follow during a recall. The website continues to describe each Class I recall in a plain language format and provides the access to the new recall database.
  • Partner with other Federal agencies, states and private-sector organizations to develop and communicate information that will encourage safe use of medical devices.Coupled with this will be technical assistance to small medical device manufacturers and accessible feedback to industry, health professionals, and consumers. This assistance is provided via Device Advice - the CDRH self-service website for medical device and radiation emitting information and feedback. Postmarket communication will be exercised through FDA Press Releases to diminish risk from medical device problems, as has been done through notifications about the potential dangers associated with blood tubing in particular configurations.


National Evaluation of X-ray Trends (NEXT)

The NEXT program is a world-recognized collaboration of FDA with the Conference of Radiation Control Program Directors, the umbrella organization of state radiation control agencies to monitor the radiation doses patients receive during diagnostic x-ray exams.

In April 2005 FDA posted an article on the Radiological Health website titled "Dental Radiography: Doses and Film Speed." The article is a result of the NEXT Dental Survey, major film manufacturer research, and other literature searches, and it documents that dentists who use a higher film speed during dental x-rays can reduce patient radiation exposure by 60 percent. The article is available at:  http://www.fda.gov/cdrh/radhlth/dentalradio.html .

 

  • Increasing safe and effective use of medical products and improving risk communication to consumers. This includes activities to:
  • Maintain the MQSA program to ensure that mammography facilities remain in compliance with established quality standards, including:
    • Certify new mammography facilities and recertify one third of the more than 9,000 existing facilities;
    • Analyze and act on inspection results to ensure compliance with quality standards;
  • Enhance the Mammography Program Reporting and Information System (MPRIS). This system improves the quality, reliability, integrity, and accessibility of facility certification, inspection, and compliance data.It also tracks and monitors the accreditation, certification, inspection, and compliance history of facilities. Facility certification information is available to consumers on the mammography website.
    • Fund annual MQSA inspections. Approximately 9 percent of mammography facilities deemed to be governmental entities are funded through budget authority. The other 91 percent of the annual facility inspections are funded through user fees.

 

FDA Strategic Goal: Increasing Access to Innovative Products and Technologies to Improve Health

 

FDA will continue to provide rapid, transparent and predictable review of marketing applications and to increase the number of safe and effective new products "including those for untreated conditions, emerging infectious diseases and counterterrorism" by improving the predictability, efficiency and effectiveness of product development; contributing to standards for performance characteristics of diagnostic devices; and increasing the quality of applications. FDA plans to:

 

Premarket Review to Advance Medical Research

  • Review premarket applications and focus resources on breakthrough medical device products and unmet needs.
  • Continue efforts to modernize its information technology infrastructure, which is critical to successful premarket review, postmarket monitoring, and document management activities. The projects include:
    • Premarket database and tracking systems to help FDA better manage review times and processes.
    • A workflow/work management system that supports core and business processes across the entire total product life cycle.
    • Electronic submission systems improvements that will result in premarket reviewer/postmarket analyst savings.
    • Overall system upgrades and other inflationary increases to add new features and improve existing capabilities to obtain work management efficiencies in premarket, postmarket, compliance and administrative areas.
    • Scheduled, systematic upgrading of reviewer personal computers (on a three-year cycle) to ensure data security, compatibility with industry submissions, and more efficient operating systems and program.
  • Work with industry and other stakeholders to develop best practice, policy and guidance documents to make premarket applications more consistent, complete, and less subject to multi-cycle reviews.
  • Maintain FDA's small business assistance program as required by the Food, Drug & Cosmetic Act.
  • Provide professional development opportunities for new and current staff. This will ensure that FDA reviewers develop and maintain the skills necessary to understand and keep pace with technologies that are rapidly developing and becoming more complex.
  • Foster education of the workforce on risk management assessment and communication. This will ensure that science-based risk management is used in all regulatory activities. It will also make sure the Agency's resources can provide the most health promotion and protection at the least cost for the public.
  • Hold public workshops to discuss challenging innovative devices for pediatric patients. These will include pediatric mechanical circulatory support devices (ventricular assist devices) and fetal monitoring devices used during delivery.

New DNA-Based Test for Cystic Fibrosis

FDA approved the first DNA-based blood test to help detect cystic fibrosis by directly analyzing human DNA to find genetic variations indicative of the disease. The test will be used to help diagnose cystic fibrosis in children and to identify adults who are "carriers" of the gene variations. FDA was able to take advantage of the automatic reclassification of class III devices (the de novo process) to bring this product to market with an expedited and streamlined 510(k) review despite the lack of a predicate device. The result is the availability of a powerful new diagnostic tool that represents a significant advance in the application of genetic technology and paves the way for similar genetic diagnostic tests to be developed in the future.

Cystic fibrosis is a serious genetic disorder affecting the lungs and other organs that often leads to an early death. It is the number one cause of chronic lung disease in children and young adults, as well as the most common fatal hereditary disorder affecting Caucasians in the U.S.The disease affects about one in 3,000 Caucasian babies. Half of the people with cystic fibrosis die by age 30.

 

Obesity, Diabetes and Cardiovascular Disease Strategies

Improve the availability of diagnostic devices and consumer information by continuing to:

  • Monitor the use and safety of new weight loss technologies through targeted postmarket plans and partnering with NIH and other collaborators.
  • Partner with sponsors on new, promising, investigational weight loss devices. These devices support the Secretary's vision of comprehensive and novel early prevention and detection strategies that increase healthy life potential.
  • Determine whether more effective but "least burdensome" regulatory mechanisms can be put into place for diabetes devices. This will assist industry in bringing to market new devices to test, monitor, and administer medications for the management and treatment of diabetes.
  • Maintain FDA's Diabetes Information website. This site provides detailed consumer information about the products that FDA regulates to diagnose and treat diabetes, with links to additional diabetic information.
  • Partner with the diagnostics industry, health professionals and diabetic organizations.This will help assure that safe and effective diagnostics are available, accurate, less invasive and easier for patients to use.
  • Maintain FDA's Heart Health Online website. The site provides consumer information about the products FDA uses to diagnose, prevent and treat cardiovascular disease, with links to additional cardiovascular information. This site was selected as one of the Biomaterials Network (Biomat.net) top five internet sites, based on general quality, scientific value and suitability to internet browsing.
  • Develop new outreach materials about implantable cardioverter defibrillators (ICDs). This will help consumers understand the risks associated with their underlying health conditions and the benefits and risks of using ICDs.

 

Third Party Review to Sustain Access to New Products

  • Continue the Third Party Review Program established under Food & Drug Administration Modernization Act. The Act was intended to encourage the use of outside scientific and technical expertise and provide an alternative to FDA 510(k) reviews. This option may be faster than reviews performed exclusively by FDA staff. It also gives manufacturers access to specialized expertise by third parties in areas such as device testing, standards, and foreign regulatory requirements. FDA will:
    • Encourage industry's use of third party reviews. Sixty-five percent of all 510(k)s are eligible for third party review, but only seven percent are submitted through this program. In 2005, the number of 510(k) submissions using the third party review program declined by 5 percent (after increasing 34 percent during the prior year).
    • Maintain FDA's third party web site that provides information on the Accredited Persons Program.
    • Maintain the Third Party Recognition Board to advise and assess new applicants, reassess existing Accredited Persons, and monitor FDA's periodic auditing of their work.
    • Encourage ongoing training for third parties to ensure consistency and quality of their reviews.
    • Complete a study based on the experience under the program and submit a report to Congress no later than January 10, 2007 on the findings of the study, as required by section 523(d) of the Federal Food, Drug, and Cosmetic Act.

 

Science and Standards to Advance Medical Research

  • Incorporate epidemiology expertise throughout the application life cycle from review into post-approval investigations.
  • Minimize burden to industry and better utilize Center expertise by leading and participating in the development of national and international product standards.
  • Promote the use of standards for manufacturing safer and more effective medical products which can speed review and enhance the quality of regulatory decision making.
  • Collaborate with National Institute of Standards and Technology (NIST) to ensure medical devices firms that are impacted by standard developments meet the public health needs and maximize medical product quality.

 

Genetic Testing

The vast majority of genetic tests are currently not regulated by FDA but are being developed as home brew assays under the authority of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). There is considerable confusion about these two different regulatory mechanisms.There is also ongoing interest in assuring appropriate assessment of technology and communication of information on new genetic tests. FDA plans to work with the Center for Disease Control and Prevention (CDC), the Center for Medicare and Medicaid Services (CMS), the Federal Trade Commission (FTC) and other agencies to:

  • Clarify regulatory choices and requirements for development of new genetic tests so that all stakeholders will understand the options available.
  • Develop mechanisms for assuring new tests are developed in a timely manner. This will be accomplished with appropriate methods of regulatory oversight; an appropriate combination of FDA, CMS, CDC and stakeholder expertise; and, when relevant, regulatory authority.
  • Develop scientific expertise and regulatory strategies for evolving medical device areas such as genetic testing. This will include working with partners such as CDC and NIST to ensure appropriate reference materials and methods are in place to support the cutting edge technologies on which genetic testing is based.
  • Ensure consumers understand the nature of tests available to them in over-the-counter settings.
  • Participate in the activities of the Secretary's Advisory Committee on Genetics, Health, and Society.
  • Research, development, and evaluation activities support this strategic goal by increasing the predictability, efficiency and effectiveness of product development and application review. This includes activities to:
    • Plan and execute special electrical and software engineering laboratory investigations. These will be used to either confirm a performance claim made by a manufacturer or determine the root cause of a medical device failure that endangers the public health;
    • Develop, using applied mathematics, appropriate methods to evaluate medical imaging system performance and dose. The results will be used in the review of premarket submissions of medical devices such as advanced ultrasound technology for both diagnosis and treatment
    • Maintain ionizing radiation measurement and calibration capabilities to support the review of new safety and security mechanisms. This supports the Agency's counter-terrorism and radiation safety activities.
    • Conduct research and regulatory reviews of possible dangerous malfunctions in devices via electromagnetic interference (EMI) from wireless equipment, such as cellular phones and magnetic-field emitting security devices.
    • Investigate safety issues related to electrophysiology and electrical stimulation medical devices for the heart and nervous system. The work is specifically aimed at forming the scientific basis for regulatory decisions, guidance documents that speed device approvals, and industry safety standards for electrical stimulation.
    • Investigate high-priority, minimally invasive optical diagnostic and therapeutic technologies to assist regulatory reviewers in a timely assessment of manufacturer's submissions.
    • Conduct laboratory research in:
      • Biological risk assessment and standards development for tissue/material interactions. These activities are designed to provide a scientific basis for regulatory decision-making in the Agency and to develop methods for risk assessment and medical device toxicology.
      • Radiation biology. This research will support the maintenance of existing regulatory standards for radiation emitting electronic products, the development of additional consensus standards, and an understanding of the effects of exposure to radiation.
      • Biomolecular mechanisms. This will help in determining whether new biotechnology developments used in the generation of new devices and diagnostic processes are safe and effective. Proposed studies will address concerns about current and impending medical device combination product submissions and the ways in which new genetic approaches can enhance genomic or genetic testing devices.
      • Mechanics of materials and medical devices. This research will provide reliable, easily interpreted methods for evaluating new heart valve designs.It will also assist in setting standards that may be incorporated into guidance and help expedite product review while maintaining patient safety.
  • Develop chemistry and materials science-oriented test methods and performance requirements for devices. This will allow the FDA to study and predict device failure modes and establish performance criteria that will help to ensure safety and effectiveness.

 

Collaboration Corrects Problems Across An Industry

CDRH issued an inspection assignment to ORA's field investigators after CDRH's review and evaluation of various data determined that many of the cochlear implant manufacturers had hermeticity and moisture problems that led to injuries in patients using these devices. Based on the findings of the inspections, CDRH conducted numerous meetings and discussions with the industry on ways to resolve the problems, including redefining moisture level specifications in the cochlear implants. Through CDRH's efforts, the industry made a number of major hermeticity and moisture level improvements that have led to a decrease in injuries.As a result of CDRH's work, the National Institute of Standards and Technology sponsored an October 2005 workshop on the biocompatibility of microchips, capacitors, and components used in implantable devices.

 

Research and Clinical Study Ethics and Integrity (Bioresearch Monitoring)

  • Maintain an effective, comprehensive inspection and outreach program. This will better assure the quality and integrity of research data upon which regulatory decisions are made and to assure the protection of human research subjects. FDA plans to:
    • Promptly evaluate and investigate allegations of research misconduct that may compromise the safety of human research subjects or undermine the quality of research data.
    • Develop a "post-approval" inspection program of premarket approval (PMA) holders. The program will assure proper conduct and reporting of CDRH required post approval study commitments.
    • Collaborate with non-compliant firms and researchers to develop corrective and preventative actions to improve human subject protection and ensure research integrity.
    • Conduct educational outreach activities and develop guidance materials for the medical device research community.
    • Develop scientific capabilities through professional staff development and contribute to major breakthroughs and novel technologies in medical device research.

 

FDA Strategic Goal: Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight

 

FDA will continue to prevent harm from regulated products by developing scientific and technical standards and systems aimed at maximizing medical product quality, and by using efficient and effective risk targeting, external partnering and collaboration aimed at detecting and intercepting substandard manufacturing processes and products. FDA plans to:

 

Risk Management

  • Develop and refine a quantifiable risk-based model that effectively manages targeted inspections of device manufacturers who produce products which pose the most significant public health risk. The model will include the use of appropriate follow-up actions to correct problems identified.

 

Import Monitoring and Inspections

  • Maintain inspection coverage for both domestic and foreign medical device as the number of medically and technologically complex devices increases. FDA will:
    • Use risk management to target inspection coverage for Class II and Class III medical device manufacturers. Domestic inspection coverage will be at 20 percent of the estimated 5,550 high-risk device statutory inventory. Foreign inspection coverage will be at 7 percent of the estimated 2,500 high-risk device statutory inventory. This coverage goal does not include any inspections conducted under the "Inspections by Accredited Persons Program".
    • Conduct criminal investigations of reported product tampering, counterfeit products and other fraudulent criminal activities involving FDA regulated products.
    • Conduct emergency operation activities, investigations and respond to incidents involving FDA regulated products.
    • Review approximately 5,700,000 device import lines requesting the admissibility of foreign manufactured devices into domestic commerce.
    • Conduct virtual training for foreign firms to assist in their efforts to voluntarily comply with FDA requirements.
    • Conduct import field examinations of imported latex products used in the treatment of or as barriers from diseases or terrorist agents.

 

Bioterrorism and Homeland Security

  • Continue to monitor, evaluate, and follow up on the public health needs of new medical devices or their use in counterterrorism preparedness and response. This will enable the FDA to regulate them in a manner that best serves the public health.
  • Evaluate the safety and effectiveness of diagnostic test kits that detect biothreat agents as well as other diagnostic and therapeutic devices being developed to address such threats. Also evaluate the performance of diagnostic test kits that detect warfare agents being marketed to the public and the government.
  • Predict and manage potential device shortages to ensure there are enough critical, commonly used devices, such as rubber gloves, to aid in rescue efforts. Develop mechanisms to use FDA's medical material shortage experts to assist in acquisition of limited critical medical countermeasures during a terrorist event.
  • Develop field expertise to sample for contamination high-risk products such as rubber gloves or surgical masks. Develop test methods for the DOD to test emergency devices for safe use on the battlefield and in civilian emergency care.
  • Participate in the development and recognition of standards originated by other agencies and outside organizations for use in reviewing and defining performance for test kits.
  • Assess the in vitro diagnostic market to determine the number and type of test kits targeted to detect terrorism activity that are being marketed to the public and government. This will provide FDA with the capability to identify manufacturers that promote diagnostic devices, to monitor their activities and to act appropriately when unsafe practices are detected.
  • Expand technical assistance to industry and DOD. In addition, expedite review, and expand outreach to civilian emergency medical professionals to give them more information about new devices in their field.
  • Maintain Continuity of Operations (COOP) and emergency response plans and emergency response training, in conjunction with HHS and FDA.

 

Radiological Counterterrorism and Radiation Safety

  • Revitalize the Radiological Health program to focus on standards, monitoring, education, research, and program management in order to:
    • Align CDRH efforts with current and evolving public health needs.
    • Expand focus on patient and consumer product experience.
    • Allow for a more targeted approach to regulation.
    • Increase information dissemination and training.
    • Improve coordination across the radiological health community.
  • Continue to monitor and assess radiation-emitting products to ensure their safe manufacture and use in existing and in new applications, such as in security or law enforcement deterrence and detection activities. This also includes:
    • Providing support to the Federal security and law enforcement agencies when requesting consult on development of such technology.
    • Ensuring manufacturers do not promote products for misuse or inappropriate use as weapons and to make recommendations and advise the public against such use.
  • Conduct Radiological Health Stakeholder Meetings. These meetings provide a forum to address significant stakeholder issues or concerns. They also help FDA obtain feedback regarding opportunities for effective collaboration with CDRH and other members of the radiological health community.
  • Continually update the FDA Radiological Emergency Response Plan as needed. Maintain preparedness through participation in interagency emergency response/counterterrorism working groups and exercises.
  • Assist the Transportation Security Administration (TSA), U.S. Customs and Border Protection, and the National Institute for Occupational Safety and Health to assure worker safety during use of non-intrusive search products which emit x-rays and the use of x-ray cargo screening and electromagnetic screening products.Provide training and support for development of radiation protection and safety programs and testing of TSA security screening equipment.
  • Conduct manufacturer inspection and targeted field testing of x-ray security screening products subject to the FDA cabinet x-ray standard.
  • Maintain the electronic reporting system. This system allows manufacturers to submit required radiation safety documentation in electronic format. It permits risk-based prioritization of submissions for review by FDA. It facilitates data analyses and sharing. It also enables more efficient use of FDA and manufacturer resources. And, finally, it helps identify product safety problems to assure the safety of workers and the public.
  • Develop a radiation safety consensus standard for cargo screening and other new non-intrusive search products that emit x-rays, neutrons or gamma rays.
  • Develop guidance for manufacturers of x-ray personnel security screening systems, and continue to evaluate and monitor new products and manufacturers in this industry.
  • Identify safer tanning techniques. FDA's optical radiation laboratory is conducting a human study entitled "Optimization of UV Exposure Patterns". The purpose of the study is to gather data to support a reduction in exposure of the public from artificial tanning devices. This data will be used to modify the present FDA and ISO standards for sunlamp products.
  • Collaborate with the Nuclear Regulatory Commission (NRC) on nuclear power plant emergency preparedness and participate in emergency exercises.
  • Coordinate with NRC to enable nuclear power plant security contractors to purchase laser products for use in security applications, which are not available on the open market.
  • Continue to evaluate the vulnerability of electronic medical implants to new security scanners, and assist in drafting a national safety standard for security screening devices. This work is being adopted by the Federal Aviation Administration in deciding the purchases of walk through metal detectors at all of the nation's airports.
  • Through the Interagency Steering Committee on Radiation Standards (ISCOR), encourage discussion among the Federal agencies with radiation control responsibilities to develop consistent policies aimed at reducing exposure for the general public. Efforts will include recommendations for appropriate use of security products and medical imaging equipment that exposes the public to ionizing radiation; continue working with ISCORS to address these radiation control issues.
  • Encourage private sector development of radiation measurement instruments to facilitate radiation testing of security screening and non-intrusive search products.
  • Prioritize and leverage FDA's radiation protection efforts with state governments, professional societies, and other Federal agencies. This will enable all these organizations to leverage their resources for the common goal of reducing unnecessary radiation exposure to the public.

 

Electro-Magnetic Interference From Security Systems

In the late 1990s, CDRH identified over 100 reports of injuries in patients with critical active implanted medical devices such as pacemakers/defibrillators and nerve stimulators. Injuries occurred when patients walked through some electromagnetic security devices like metal detectors.Preliminary CDRH measurements confirmed that some devices emitted relatively strong magnetic fields.With no standardized test methods addressing security systems emissions, CDRH engineers developed a new test method and novel simulator to generate electromagnetic fields similar to any security device. The results of this work help biomedical engineers and manufacturers of medical devices and security systems to identify incompatible combinations of emitters and victims early in the development stage, thus preventing injuries for vulnerable medical device patients.

CDRH used the expertise they developed on this subject in numerous premarket reviews, and published the simulator details and test results in peer reviewed journals. They are working with several international standards setting organizations to adopt this FDA-developed technology.

 

International Activity Collaborations

  • Maintain the U.S./European Community (EC) Mutual Recognition Agreement to help reduce the number of foreign firms FDA staff need to inspect. This will be accomplished by relying on FDA inspections conducted by listed European Unions Conformity Assessment Bodies.
  • Implement a pilot program to assess the feasibility of using an internationally harmonized format in the review of submissions for device safety and performance.
  • Develop and maintain information about EU-based medical device manufacturers. Provide more information about the status of those manufacturers to help expedite product approval.
  • Develop a mechanism for recognizing symbols for use in in vitro diagnostic labeling to allow for harmonization of package inserts.
  • Continue FDA's participation as a member of the Global Harmonization Task Force to ensure a leadership role in the global market.
  • Prepare and disseminate information on how FDA will regulate emerging technologies to help support FDA's role in international harmonization on emerging technologies; and,
  • Develop and implement a third party pilot program to perform multipurpose audits of medical device manufacturers covering both US and Canadian requirements.

 

Inspections by Accredited Persons

Maintain the MDUFMA-authorized program to accredit third persons (Accredited Persons) to conduct inspections of eligible manufacturers of Class II and Class III medical devices.This program is independent of third party inspections performed under the current US/EC Mutual Recognition Agreement and offers companies that use the program, if they are doing business globally, the option to coordinate required inspections so that one appropriately certified third party can perform an inspection that may satisfy more than one regulatory authority- thereby limiting the disruption to production that is associated with multiple inspections. FDA will continue to:

  • Accept and review applications from establishments wishing to be certified as an Accredited Person (AP) and sponsor classroom training as new firms are accepted into the program;.
  • Continue performing joint inspections to qualify APs to perform independent inspections.
  • Continue to promote the program to regulated industry.

 

Bovine Spongiform Encephalopathies (BSE) and Transmissible Spongiform Encephalopathies (TSE)

BSE, also known as "Mad Cow Disease," is a deadly, degenerative disorder of the central nervous system. TSE includes a group of related human and animal diseases that are fatal to humans and animals and for which there is no treatment or preventive vaccine. FDA plans to:

  • Maintain current Field Investigator's Guidance for Manufacturing Facilities. The current scientific understanding of TSEs and their potential risks are changing rapidly. Resources are needed for educational activities and document revision as our understanding changes to keep the guidance documents and field investigations scientifically accurate.
  • Maintain a device tracking/animal materials data base for identifying/tracking devices containing or manufactured from animal-derived source material.
  • Examine ways to prevent the transmission of TSE-related diseases during the use and reuse of medical instruments.
  • Evaluate decontamination procedures for device manufacturing processes, including equipment and facilities, and for medical instruments; and to consider the recommendations and deliberations of the advisory panel on this topic.

 

Clinical Laboratory Improvement Amendments (CLIA)

  • This activity is funded by a portion of the CLIA user fees collected by the Centers for Medicare and Medicaid Services. FDA has been assigned the responsibility for developing policy and performing reviews to establish the complexity categorization of all new laboratory tests. This work determines the types of laboratory setting appropriate for each laboratory test and contributes to ensuring both quality and access to important testing technology.

 

FDA Strategic Goal: Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21st Century

 

FDA works to increase the quality, effectiveness, and adaptability of the FDA workforce and to improve capability and capacity for highly coordinated and integrated operations. FDA will:

  • Provide leadership to industry in the development of innovative approaches for the evaluation of medical device safety and effectiveness; and,
  • Support the President's Management Agenda and competitive sourcing A-76 efforts by performing cost comparison studies for identified functions.

In addition, FDA plans to relocate CDRH's engineering and physics research programs to FDA's consolidated campus at White Oak. FDA needs to allocate funds to provide basic laboratory support equipment, such as biosafety cabinets and autoclaves, and for research instrumentation, such as electron microscopes and lasers.

 

Selected FY 2005 Accomplishments

 

FDA Strategic Goal: Enhancing Patient and Consumer Protection and Empowering Them with Better Information about Regulated Products

 

Modernize Medicare and Medicaid

  • Home Health Care Initiative - Continued Home Health Care Initiative efforts to address the needs of a growing number of patients using clinical medical devices at home. A prototype was developed and is now under Center review for an electronic repository for manufacturers' infusion pump labels containing pump information and instructions for use.

 

Improve Problem Detection and Management

  • Postmarket Safety Studies - Implemented a new system for the oversight of Post-Approval Studies program. This program involves the design and tracking of clinical studies that are required of manufacturers as a condition of approval of a PMA.
  • Evaluation of CDRH Postmarket Program - Conducted an evaluation of the Postmarket program. The evaluation is documented in a report, CDRH Postmarket Safety Framework. CDRH established a senior level team who will be responsible for evaluating the recommendations, overseeing the setting of priorities, and monitoring the action items selected for program improvement.
  • Medical Devices Adverse Events - Received, processed, and analyzed over 180,000 medical device adverse events reported through CDRH's Medical Device Reporting (MDR) system. This system detected and CDRH responded to numerous public health issues ranging from orthodontic headgear, hemodialysis systems and hospital beds, to cochlear implants, deep brain stimulators, and diagnostic tests for heart attack and pregnancy. CDRH began developing an electronic adverse event reporting system that will facilitate processing the reports and also reduce operating costs.
    • MedSun is a national network of healthcare facilities trained to recognize and report problems, with an active component that includes targeted surveillance and networks able to provide "real-time" data. MedSun expanded to approximately 350 healthcare facilities. MedSun conducted activities including a pilot program for CBER and MedSun sites to acquire information for that Center on issues involving human cells and tissues; audio conferences for all MedSun sites; a workshop on infusion pump safety; a Device Safety Exchange Program for online sharing of questions and device quality improvement ideas by MedSun reporting sites; and training on problem recognition with laboratory and pediatric devices.
    • MedSun reports contributed to, numerous regulatory actions.In one instance, a patient died when a machine failed in a non-safe mode when a nurse inappropriately responded to an alarm. This report prompted FDA actions including the investigation and finding of a significant design issue related to this continuous renal transfusion device, a public health notification warning of this issue, and cooperative efforts with the company to issue a product recall.

 

Communicate Risk More Effectively

FDA increased access to information on its websites, in newsletters, through increased outreach efforts, and through internal operational initiatives. Highlights include:

  • Cooperative Relationships -
    • In conjunction with the Heart Rhythm Society (HRS), held a policy conference on implantable cardioverter defibrillators (ICDs) and pacemakers. The conference reviewed current process for recalls. There was also discussion on the important elements of risk communication that can help guide physicians in treating patients with recalled defective devices.
    • Posted a laboratory safety tip on a CDRH webpage as a follow-up to a signal identified from MDR reports and literature. The signal was on falsely elevated results for Troponin, an indicator test for heart attack. As an example of leveraging with industry to address an educational need, AdvaMed, a trade association of medical device manufacturers, drafted the tip in response to FDA concerns.
    • Medical Device Safety Website - Maintained the Medical Device Safety website for health care professionals. The site consolidates all of CDRH's medical device safety information (recalls, public health notifications, safety tips, etc.) and is updated regularly with high priority risk messages.
    • Public Health Notifications - Issued notices on the Public Health Notification website (www.fda.gov/cdrh/safety) HH to mitigate risk from medical device problems. The notifications covered issues such as Ralstonia bacteria contamination of a humidifier used in neonates, information regarding failures with the Guidant Implantable Cardioverter Defibrillator, and recommendations to avoid entrapment of vulnerable patients in the Vail bed.
    • FDA Patient Safety News (FDA PSN) -Coordinated the production of FDA Patient Safety News, an award-winning monthly television news show and website (www.fda.gov/psn) distributed to health care practitioners across the nation. FDA PSN covers stories on medical errors, patient safety, recalls and alerts, and newly approved drugs, devices and biological products. The website receives about 8,500 "hits" per month, an increase of about 40% over the previous year.
    • Medical Device Recall Website - Redesigned the website to provide a web-friendly, plain language overview of medical device recalls. The website explains the various classes of recalls and the procedures followed during a recall. Other highlights include:
      • E-Consumer Initiative - Explored ways to improve access to CDRH's electronic information. New features were added to the CDRH website to offer users options for receiving information.

 

For Youth and Mature Adults … Health Matters

CDRH leads FDA's efforts to reach all consumers "including youth and older adults"with medical information important to maintaining good health."Maturity Health Matters," a newly-launched online newsletter, is geared toward providing FDA regulated product information of interest to the older adult population. This newsletter focuses on FDA regulated products that help people live longer and more productive lives.  www.fda.gov/cdrh/maturityhealthmatters/ .

The FDA & You newsletter targets secondary school students and Health Educators. FDA & You provides information on FDA topics of interest to teenagers. www.fda.gov/cdrh/fdaandyou/index.html .

 

MQSA - Mammography Quality Standards Act

  • Commemorated 10 years of MQSA Inspections.
  • Completed 93,000 facility inspections nationwide.
  • Conducted annual inspections of over 9,000 mammography facilities nationwide.
  • Ensured that 98% of mammography facilities met inspection standards. Less than 2% had level 1 problems.FDA worked with each of those facilities to assure adequate corrective action was taken.

 

Research, Development And Evaluation Activities

CDRH conducted applied research that expanded patient protection, including:

  • Developed and validated a method for assigning an accurate expiration date for medical gloves. This work is critical to protect patients and health care workers from transmitting infectious diseases/agents used in terrorist activities.
  • Conducted research on mechanical strength improvement in vertebrae following bone glue injections. This is the most common treatment for compression fractures, estimated to eventually affect a quarter of all women over age 50.
  • Measured and modeled exposure to electromagnetic fields and their effects on implanted devices from hand held and walk through security systems, cellular telephones, hand-held computers, and MRI systems. This included models of the head for evaluation of cell phone exposure and of pregnant woman models for 9 gestational ages of the fetus for heating during MRI.

 

Bioresearch Monitoring (BIMO)

FDA invoked the Application Integrity Policy (AIP) against a manufacturer and distributor of drug of abuse test kits after significant questions arose concerning the integrity of data submitted to the Agency. This achievement effectively removed thousands of potentially inaccurate and ineffective diagnostic drugs of abuse test kits from the marketplace. Because of this action, FDA suspended the substantive review of eight (8) of the manufacturer's pending 510(k) marketing submissions, and the manufacturer subsequently withdrew 18 additional cleared 510(k) marketing submissions due to widespread data inconsistencies and questionable design and research practices

 

FDA Strategic Goal: Increasing Access to Innovative Products and Technologies to Improve Health

 

Medical Device User Fee and Modernization Act of 2002, P.L. 107-250 (MDUFMA)

FDA continued to implement MDUFMA of 2002. FDA used the additional funds to hire staff expertise and develop better systems and infrastructure to support more effective and timely premarket review. The law requires FDA to pursue a complex and comprehensive set of review goals that are more aggressive each successive year. In 2005 CDRH fulfilled the MDUFMA statutory requirements and maintained device review performance in areas not covered by official performance goals.

  • Guidance -Issued six MDUFMA guidance documents in 2005 to facilitate interactions with industry and ensure effective program implementation. The agency has issued guidance documents on premarket approval applications, premarket assessment of pediatric medical devices, 510(k) submissions, use of validation data in 510(k) submissions for reprocessed single use devices, and the Inspection by Accredited Persons Program. (See http://www.fda.gov/cdrh for specific guidances.)
  • Documents, Notices and Reports- Developed three Federal Register notices relating to MDUFMA implementation. In addition, CDRH issued three reports to Congress: Annual report to Congress on the Office created to coordinate and monitor the review of combination products - for FY 2004; Annual Financial Report to Congress -for FY 2004; and Annual Performance Report to Congress -for FY 2004. A complete listing is available at http://www.fda.gov/cdrh/mdufma/index.html.
  • Scientific Expertise to Enhance Capability - Increased MDUFMA hires and brought in 74 new experts under the Medical Device Fellowship Program (MDFP). MDFP reinstituted the National Research Council Associates Program contract to operate a Resident Research Associateship Program and finalized an MOU with Duke University and Brigham and Women's Hospital. These programs provide doctoral scientists and engineers of unusual ability.
  • Third Party Inspection Program - Continued implementing the MDUFMA Accredited Persons (APs - Third Party inspection) program. The program is designed to reduce regulatory burden on providers, patients, and consumers of HHS services by increasing efficiency and modernizing regulatory oversight. During 2005, the number of qualifying inspections for APs increased by 10%. Currently, 5 of 16 APs are eligible to conduct independent inspections on behalf of the FDA.CDRH announced, in a letter to 8,600 domestic Class II and Class III device establishments, the publication of the AP Eligibility Guidance and outlined the benefits to manufacturers who use an AP to conduct their AP inspections.

 

Innovations In Patient Care

The following devices are examples of advanced device technologies that FDA approved or cleared during FY 2005 that have a particular impact on patient care.

  • DuraSeal Dural Sealant System - the first dura mater sealant for neurosurgery:

    The DuraSeal Dural Sealant System by Confluent Surgical, Inc. is the first material approved for sealing leaks in the dura mater covering of the brain during neurosurgical procedures. The absorbable sealant is intended to aid in preventing cerebrospinal fluid leakage through suture wound edges of the dura mater.

Diagram of the device

  • Total Temporomandibular Joint Replacement System -  new prosthetic jaw joint:
    • The Total Temporomandibular Joint Replacement System, by Walter Lorenz Surgical, Inc., is a prosthetic jaw joint for patients who need a total jaw replacement due to severe arthritis, fused joints, severe fractures, tumors, or severely degenerated joints. The device is a ball and socket joint that may reduce jaw pain, reduce interference with eating and increase the ability to open the mouth.
    • Invader® UGT1A1 Molecular Assay - The first DNA-based test for an enzyme that metabolizes certain drugs: With the Invader® UGT1A1 Molecular Assay, from Third Wave Technologies, Inc., doctors can use a patient's genetic information to help them determine whether to modify the dose for drugs that are broken down in the body by UGT enzymes. The Invader assay will help to minimize harmful drug reactions and prevent patients from being improperly treated with sub-optimal doses. It joins a growing list of DNA-based tests used for individualized medical care.
    • VeriChip Implantable RF Transponder System - new technology for maintaining patient data: The VeriChip Implantable Radiofrequency Transponder System, from Applied Digital Solutions, consists of an implantable chip, an introducer, and a reader.After the chip is implanted under the skin, a caregiver is able to retrieve a unique patient identifier and patient medical information from a prescription web site when the patient is otherwise unable to provide this information.The medical information on the websites is supplied by the patient and can only be accessed with appropriate authorization.
  • CoAxia NeuroFlo™ Catheter-approved under the Humanitarian Device Exemption (HDE) program: The NeuroFlo™ Catheter, from CoAxia, Inc., is used to treat cerebral ischemia (insufficient blood flow to the brain) resulting from the spasm (squeezing down) of a blood vessel in the brain that results in stroke-like symptoms. The catheter is intended to increase blood flow to the upper body and brain by temporarily reducing blood flow to the lower part of the body.

    Catheter and a Penny

 

Rapid, Transparent Device Reviews

  • CDRH approvals - 38 Premarket Approval Applications (PMAs) and cleared 2,617 510(k) submissions for products that will treat or diagnose a wide variety of medical conditions.FDA used the de novo process to automatically reclassify certain class III devices that have no precedent, but whose technology is well understood. This process allows products to come to market through the less burdensome 510(k) review process, and exemplifies FDA's effort to provide the most rapid, cost-effective health promotion and protection for the public.

 

Leveraging Expertise to Supplement Review Decisions

  • Advisory Committees - CDRH held 17 Federal Advisory Committee panel meetings in 2005. These panels of external experts reviewed and made recommendations to FDA on 10 PMAs, one humanitarian device exemption (HDE), two 510(k)s, five preamendment device classifications, and six general issues.
  • Third Party Review Program - CDRH increased the use of the Third Party Review Program for 510(k) submissions.CDRH also made final decisions on 251 "third party" 510(k)s, an increase from the 244 final decisions in FY 2004.

 

Improving Application Quality

  • Premarket Review Quality Assessment - CDRH instituted an on-going quality review program for premarket submissions that evaluates the quality of its scientific review in three key areas:biocompatibility, sterilization and statistical analysis. This process allows CDRH to improve the quality of reviews in key scientific areas, thus ensuring that reviewers consistently ask the right questions at the right times.
  • Guidance for Regulated Industry
    • Regulations and Guidance Development - CDRH streamlined guidance development by prioritizing its guidance workload; establishing performance goals and tracking mechanisms; engaging industry stakeholders in the early stages of guidance development; and increasing the use of contract experts. The Center also worked with the Office of General Counsel and the Office of Policy Regulation editorial staff to review and revise the boilerplate Guidance Development Templates for all guidance documents. These templates are available on the Center's web site: www.cdrh.fda.gov/LAWS/GGP/default.htm.
    • CDRH issued 28 guidance documents, cleared four draft Guidance documents, drafted nine responses to Citizen Petitions, published 16 final rules, published 47 Notices and issued several device-specific and special control guidance documents, including a guidance for intravascular stents and a guidance providing clarity on indications for implanted cardioverter defibrillators. CDRH issued key cross-cutting guidance documents related to software used in medical devices and a guidance document on the Format and Content of 510(k) submissions.
  • Workshops
    • Significant Item: Glucose Monitoring - FDA, in conjunction with NIH and the Juvenile Diabetes Research Foundation (JDRF), held an open public workshop entitled "Obstacles and Opportunities on the Road to an Artificial Pancreas:Closing the Loop" on December 19, 2005.Obstacles to development of new technologies for diabetes monitoring were discussed and suggestions made for how to deal with them. FDA offered to review research proposals from JDRF to assist them in launching and managing a new research initiative in the area of non-invasive glucose testing.
  • Small Manufacturers and International Assistance - CDRH helped small manufacturers and international producers comply with FDA requirements.CDRH answered 44,000 requests for information; 7,000 responses involving international activities; and distributed 82,000 guidance documents on inspection and enforcement procedures, product development, and regulatory submissions.

 

Research, Development And Evaluation Activities

Applied research advances innovative technologies and consumer health. CDRH research contributes to the internal review process as well as to the development of guidance for industry in the development of innovative technologies:

  • Evaluated the effects of optical energy on cellular and intracellular structures and components. This resulted in improved understanding of the effects of light on energy production in cells. This work, supported in part by an interagency agreement with the Air Force Office of Scientific Research, resulted in four journal articles, numerous proceedings and presentations during the past year, and a proposal to the Army's Telemedicine and Advanced Technologies Research Center to evaluate optical methods of stimulation that may enhance the field of neuro-prostheses.
  • Enhanced understanding of the device-tissue interface for optical spectroscopy leading to improvements in the efficiency of spectroscopic methods for minimally invasive disease detection. This has the potential to improve the detection of mucosal cancers and the monitoring of changes following therapeutic applications. This work resulted in two journal articles and five proceedings publications during the past year.

 

Efficient, Effective Predictable Product Development

  • Critical Path
    • Workshop on Drug-Diagnostics Translational Research - Held, in April 2005, the third in a series of national workshops on the co-development of drugs and diagnostics to give stakeholders a public venue for scientific suggestions and concerns about FDA regulatory practices in this important and growing new area. FDA is using the proceedings of this conference to develop guidance to ensure that this type of research translates in a rapid and cost-effective manner to new joint products that can quickly enter the medical marketplace. The new field of pharmacogenetic research will enable pharmaceutical companies to develop drug treatments that precisely target the needs of particular patient populations. By linking drug treatments to diagnostic tests that can accurately identify appropriate receptive patients, pharmaceutical companies aim to decrease drug adverse events, increase drug response rates, and ultimately save healthcare dollars.

 

FDA Strategic Goal: Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight

 

Risk-Based Management

Continued to refine the risk-based management program for inspection and enforcement actions. This program not only impacts how inspections areprioritized, but will help identify and prioritize other types of regulatory activities, such as device recalls, that present the greatest risk to public health. CDRH analyses of past inspection data is used to make decisions on inspection priorities and regulatory actions. CDRH analyzed 132 Warning Letters issued to medical device manufacturers, finding 75 percent of the citations related to GMP violations and 24 percent related to MDR violations.

  • Enforcement
    • Completed administrative and judicial actions to protect the American public. CDRH processed 70 warning letters and 437 product recalls, including 20 highest-risk Class I, 349 Class II, and 68 Class III recalls.Highlights include:
    • Conducted seizure of Baxter Healthcare Corp. infusion pumps because inspections revealed that the firm had continually failed to follow medical device manufacturing controls. Baxter had previously initiated a worldwide recall of the infusion pumps because they could shut down while delivering critical medication and fluids to patients.
    • Class I recall: Abbott Diabetes Care, Inc. recalled its Blood Glucose Meters when an investigation of reported problems showed that the monitor could inadvertently switch the glucose readings from the U.S. to the foreign standard when it is dropped or upon battery replacement. Misinterpreting the results caused by the switch could result in patients developing hyperglycemia, which is particularly harmful to pregnant women and could lead to fetal damage. FDA classified this as a highest-risk Class I recall and dispersed the notice through all of its communications channels.
  • Inspections

    CDRH coordinated with the Office of Regulatory Affairs (ORA) and provided technical support, as necessary, for inspections. The Agency surpassed all inspection goals:

    • Exceeded the goal of 20% of 5,520 registered domestic Class II and Class III medical device manufacturers by conducting 1,265 inspections;
    • Exceeded the goal of 7% of 2,500 registered foreign Class II and Class III medical device manufacturers by conducting 230 foreign inspections; and
    • Exceeded the goal of 295 domestic and foreign BIMO inspections by conducting 335 BIMO inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations.
  • Clinical Laboratories Improvements Act (CLIA)
    • Established quality standards for all laboratory testing to ensure accurate, reliable and timely patient test results regardless of where a test was performed. Tests are categorized by their complexity (i.e., potential risk to public health,) and laboratories may only purchase and use a particular test based on the laboratory's level of CLIA certification.
    • Completed, during 2004, the delegation of authority to FDA for CLIA complexity determinations and finalized a 5-year Interagency Agreement with the Centers for Medicare and Medicaid Services (CMS) for CLIA waiver authority.
    • Published a draft guidance for the waiver process.Comments have been received and the guidance is currently being revised.

 

Radiological Health New Direction

CDRH's Radiological Health activities provide expertise for the review and approval of treatment and therapy systems, for preventing excessive radiation exposures from diagnostics examinations such as fluoroscopy, and for monitoring and evaluating radiation emitting products such as security screening devices used to guard against terrorist threats.

  • Protective Activities
    • X-rays - Promulgated amendments to the Federal radiation-safety standard, improving the performance of diagnostic x-ray systems and their major components while significantly reducing unnecessary x-ray exposure, especially in fluoroscopy, and maintaining image quality. The expected improvement in the quality of health care is projected to reduce the annual U.S. population dose by over 7,000 person-sievert, which is associated with a projected annual reduction in over 200 cancer deaths and annual savings of over $300 million.
    • Lasers -Briefed House Science Committee staff in January 2005 on its authorities regarding the manufacture and use of laser products. Additionally, in response to reports of green lasers directed at aircraft to distract or temporarily flash-blind the crew, FDA assessed the impact of legal and illegal use of radiation-emitting products and worked with the Federal Aviation Administration (FAA), Department of Homeland Security (DHS) and Department of Defense (DoD) to address this problem. FDA published and contributed to public information regarding safe use of laser pointers and cautioned against internet sales of laser products through various print media outlets and on the Internet. FDA took action against firms that sell modified green lasers that emit radiation in excess of the limit for general public use.

 

Emergency Preparedness

CDRH routinely consulted with other government agencies on diagnostic and monitoring devices, radiological counter measures and radiation-emitting devices with potential to be used as weapons (e.g., visible lasers) and on radiation safety issues, including preventing unnecessary radiological exposure from security screening products.

  • Formed a working technical group to address the use and rapid approval of diagnostic devices related to influenza and is assisting CDC in making available to the laboratory response network CDC's rapid diagnostic test for avian flu.
  • Began, in September 2005, , posting hurricane- and pandemic flu-related emergency information on its website, www.fda.gov/cdrh/emergency/index.html.This was in as a response to the Katrina emergency and to increased national efforts on flu pandemic.
  • Posted information on cleared and approved devices for personal protection on its emergency information website, www.fda.gov/cdrh/emergency/flu_qa.html.These devices are integral to minimizing the spread of infectious agents, including those used in bioterrorism.

 

FDA Strategic Goal: Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21st Century

 

Improved Management - IT

  • Systems development in 2005 included tracking Conditions of Approval postmarket studies, electronic consultations tracking (eConsult), a Device Nomenclature Management System, and enhancements to electronic submissions of in vitro diagnostics (IVD) applications, and implementation of a program for accepting electronic premarket submissions (eCopy).
 Devices and Radiological Health
Program Activity Data (PAD)
PROGRAM WORKLOAD AND OUTPUTS FY 2005 Actual 1/ FY 2006 Estimate FY 2007 Estimate
Expedited Original PMA MDUFMA Decision Goal (% of decisions within # of FDA days) 70% in 300 days 80% in 300 days 90% in 300 days
Expedited PMA Received 5 9 9
Expedited PMA Approved
2
9
9
Expedited PMA - Performance 100% in 300 days 80% in 300 days 90% in 300 days
PMA original, panel track supplement and premarket report submissions MDUFMA Decision Goals (% of decisions within # of FDA days) NA 80% in 320 days 90% in 320 days
PMAs Received
(PDP and PMA)
49 50 50
PMAs Approved
( PDP and expedited)
38 43 43
Original PMA performance 100% in 320 days 80% in 320 days 90% in 320 days
 PMA Supplement Panel Tracks2/ Received 12 12 12
PMA Supplement Panel Tracks2/ Approved 9 12 12
Panel track PMA Supplement2/ performance 100% in 320 days 80% in 320 days 90 % in 320 days
Humanitarian Device Exemptions Received 4 6 6
Humanitarian Device Exemptions Approved 2 5 5
Average HDE FDA Review Time (FDA days approval) 222 150 140
180- day PMA Supplements MDUFMA Decision Goal (% of decisions within # of FDA days) 80% in 180 days 80% in 180 days 90% in 180 days
PMA Supplements Received 97 110 110
PMA Supplements Approved 79 100 100
PROGRAM WORKLOAD AND OUTPUTS FY 2005 Actual 1/ FY 2006 Estimate 3/ FY 2007 Estimate
180-day PMA supplement performance 97% in 180 days 80% in 180 days 90% in 180 days
510(k) MDUFMA Decision Goal (% of decisions within # of FDA days) 75% in 90 days 75% in 90 days 80% in 90 days
510(k)s Received (Trad., Special, Abbrev., 3rd party) 3,650 3,600 3,600
510(k)s Completed (All Decisions) 2,617 3,500 3,500
510(k) performance 95% in 90 days 75% in 90 days 80% in 90 days
Investigational Device Exemptions Received 232 230 230
Investigational Device Exemptions Decisions 244 220 220
% Acted on Within 30 Days 100% 100% 100%
InvestigationIDE Supplements Received 4,282 4,300 4,300
IDE Supplements (Approved/Total Decisions) 4,249 4,300 4,300
% Acted on Within 30 Days 100% 100% 100%
Total Standards Recognized for Application Review 695 750 775

1/Data represents CDRH contributions to the categories listed above and are current as of 1/1/2006. Performance totals for FY 2005 are subject to change as the cohort matures. FDA is committed to meeting the performance goals cited in the MDUFMA legislation. User fees, coupled with the increased appropriated resources for medical device review received in FY 2005, will enable FDA to meet the aggressive premarket goals agreed upon by FDA and its stakeholders. The FY 2005 requested increase will strengthen the capabilities needed to meet the increased performance goals by building the medical device review infrastructure and hiring new reviewers. Outputs are not expected to increase until FY 2006 and FY 2007 when the infrastructure is in place and functioning and the new reviewers are on board and fully trained. Increased outputs in FYs 2006 and 2007 are contingent upon receipt of MDUFMA user fee revenue.

2/ A "Panel-Tracked" PMA supplement is a supplement to an already approved PMA and is usually for a change in the indications for use statement. The change in indications statement is usually for a new use of the already approved device (not change to the device), for use in a different disease condition, for use in a different anatomical site, or for use in a different patient population. A summary of safety and effectiveness information is prepared and made available to the public.

3/ Includes filing decisions, review determinations, and approval decisions.

DEVICES FIELD PROGRAM
OUTPUTS-DOMESTIC INSPECTIONS
FY 2005
Actual
FY 2006
Estimate
FY2007
Estimate
Bioresearch Monitoring Program Inspections
329
300
300
Pre-Approval Inspections
64
130
130
Post-Market Audit Inspections
63
65
65
GMP Inspections (Levels I, II, III and Accredited Persons)
1,430
1,530
1,530
Total Above Domestic Inspections: Non MQSA
1,886
2,025
2,025
Inspections (MQSA) FDA Domestic (non-VHA)
366
335
371
Inspections (MQSA) FDA Domestic (VHA)
32
32
32
Inspections (MQSA) by State Contract
8,340
7,924
7,700
Inspections (MQSA) by State non-Contract
545
530
530
Total Above Domestic Inspections: MQSA
9,283
8,821
8,633
Total Domestic Reinspections (Non-add)
237
237
237
State Contract Devices Funding
$1,350,000
$250,000
$275,000
State Contract Mammography Funding
$9,800,000
$9,200,000
$9,940,000
Total State Funding
$11,150,000
$9,450,000
$10,215,000
Domestic Radiological Health Inspections
107
130
130
Domestic Field Exams/Tests
944
1,215
1,215
Domestic Laboratory Samples Analyzed
200
217
217
PROGRAM OUTPUTS-IMPORT/FOREIGN INSPECTIONS  
 
 
Foreign Bioresearch Monitoring Inspections
6
10
10
Foreign Pre-Approval Inspections
17
34
34
Foreign Post-Market Audit Inspections
26
27
27
Foreign GMP Inspections
225
207
189
Foreign MQSA Inspections
16
15
15
Foreign Radiological Health Inspections
9
19
19
Total Above Foreign FDA Inspections
299
312
294
Total Foreign Reinspections (Non-add)
24
24
24
Import Field Exams/Tests
6,901
5,000
5,000
Import Laboratory Samples Analyzed
1,333
1,440
1,440
Import Physical Exam Subtotal
8,234
6,440
6,440
Import Line Decisions
3,484,393
4,460,023
5,708,829
Percent of Import Lines Physically Examined
0.24%
0.14%
0.11%

 

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