• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Devices and Radiological Health

<< Return to FY 2005 Budget Proposal

 

Department of Health and Human Services
Food and Drug Administration
Fiscal Year 2005

 

MEDICAL DEVICES AND RADIOLOGICAL HEALTH

 

  FY 2003
Actual
FY 2004
Enacted 1/, 2/ 
FY 2005
Estimate
Increase
or Decrease

Program Level

$217,285,000 $224,664,000 $251,795,000 + $27,131,000
     Center
$155,121,000
$162,718,000
$188,568,000
+$25,850,000
     FTE
1,003
1,139
1,198
+59
      Field
$62,164,000
$61,946,000
$63,227,000
+$1,281,000
     FTE
482
505
513
+8
Budget Authority $193,350,000 $191,144,000 $216,699,000 + $25,555,000
     Medical Device Review
     FTE
$96,061,000
$115,527,000
$141,082,000
+ $25,555,000
Budget Authority FTE 1,432 1,453 1,503 + 50
User Fees $23,935,000   $33,520,000 $35,096,000 + $1,576,000
     MDUFMA $11,065,000  $17,142,000 $18,379,000 +$1,237,000
     FTE
17
143
160
+17
     MQSA
$12,870,000
$16,378,000
$16,717,000
+$339,000
     FTE
36
48
48
0
User Fee FTE 53  191 208 + 17
1/Contains a Budget Authority rescission of 0.59 percent for a total of $1,134,000 for the Medical Devices and Radiological Health.
2/  In FY 2004, a total of 104 Human Resources FTE were transferred from the FDA to the Department as part of the Secretary's One HHS Initiative.  The Medical Device and Radiological Health Program's share of this transfer was 11 FTE.

 

Historical Funding and FTE Levels

 

Fiscal Year Program Level Budget Authority User Fees Program Level FTE
2001 Actual
177,565,000
165,306,000
12,259,000
1,472
2002 Actual5/
193,657,000
179,962,000
13,695,000
1,454
2003 Actual
217,285,000
193,350,000
23,935,000
1,485
2004 Enacted
224,664,000
191,144,000
33,520,000
1,644
2005 Estimate
251,795,000
216,699,000
35,096,000
1,711
5/ Includes FDA's FY 2002 Appropriation and the Counterterrorism supplement

 

MISSION

 

The Devices and Radiological Health program promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.  The aim of the program is to:  

  • Meet all statutory responsibilities for review of new medical devices;
  • Assure medical product safety by monitoring the use of all medical devices, and the function and use of radiological health;
  • Manage emerging hazards to prevent widespread health and safety threats and ensure safe and effective new technologies;
  • Apply the Total Product Life Cycle model across the range of Devices and Radiological Health activities, by covering products from concept to obsolescence;
  • Connect to the global public health community, and partner with stakeholders;
  • Use science in the regulatory process to the maximum extent;
  • Attract and retain a diverse and high quality workforce; and,
  • Measure and set targets to program's impact on public health.

 

BACKGROUND

 

CDRH regulates a wide array of medical devices, from artificial hearts, pacemakers, and drug-coated stents; to deep brain stimulators and spinal implants; dialysis machines and infusion pumps; intraocular lenses and cochlear implants; robotic surgery devices and stair-climbing wheelchairs; to 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. Many of these counterterrorism activities include expediting review of Bioterrorism diagnostics, managing product shortages, supporting safe and effective development and use of battlefield and emergency devices, and ensuring safe use of people scanners in airports and other security systems, and assessing radiation products for misuse as weapons.

The Field component, the Office of Regulatory Affairs (ORA) supports the Center for Devices and Radiological Health. ORA conducts 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. The Field also conducts risk-based domestic and foreign postmarket inspections of medical device manufacturers to assess their compliance with Good Manufacturing Practice requirements to include inspections of reprocessors of single-use devices.  ORA also monitors imported medical devices and radiological products through field examinations or sampling, as needed, to ensure the safety of such products.

In addition to overseeing regulated products on a surveillance or "for cause" basis when a problem is encountered, ORA staff also responds to emergencies and investigates incidents of product tampering and terrorist events or natural disasters that may impact FDA regulated goods. To complement the regular field force, the Office of Criminal Investigations investigates instances of criminal activity in FDA regulated industries.

 

Device and Radiological Health Program Increases for FY 2005
By FDA Strategic Goal

 

FDA Strategic Goal FY 2005 Increase What the Increase Buys Related Program Goal(s)
Strong FDA

Medical Device Review --

+$3,900,000 Budget Authority

  • Maintain current staffing levels with cost of living increases;
  • Enhance reviewer  training and skill maintenance; and,
  • Enhance office and laboratory infrastructure.
  • Provide a strong infrastructure by maintaining current staff, enhancing reviewer training and skill and improving office and laboratory infrastructure.  All CDRH goals support the strong FDA initiative. **
Efficient Risk Management:  The Most Public Health Bang for Our Regulatory Buck

Medical Device Review --$21,655,000

Medical Device Review--$1,237,000

User Fee

  • Improve the review of expedited submissions for medical devices;
  • Improve review performance where fees are collected and maintain performance in other areas;
  • Enhance the IT systems that support the current review process;
  • Work with subject matter experts to develop guidance and standards;
  • Expand FDA's small business assistance program;
  • Conduct pre-approval inspections for device manufacturers; Enhance policy and guidance document development, emergency response, review management and risk communication to respond to terrorist threats and security crisis;
  • Contract with professional societies and agencies to determine needs for the Agency, including labs, to plan bio-effects research, and develop safe use requirements; and;
  • Acquire and train staff to meet a set of aggressive performance goals that take effect in FY 2006.
  • Complete Review and Decision on 70 percent of Expedited PMAs within 300 days;
  • Complete Review and Decision on 80 percent of 180 day PMA supplements within 180 days;
  • Complete Review and Decision on 75 percent of 510(k)s (Premarket Notifications) within 90 days;
  • Conduct 295 domestic and foreign BIMO inspections with an emphasis on vulnerable populations;
  • Expedite review for designated PMAs to include completing an estimated 5 Bioterrorism Diagnostic Medical Device Applications;**
  • Reduce the average time for marketing approval for safe and effective new devices;*
  • Complete Review and Action on 90 percent of PMAs of an estimated 80 first actions within 180 days;**
  • Complete Review and Action on 95 percent of an estimated 725 PMA supplement final actions within 180 days;**
  • Complete Review and Action on 95 percent of an estimated 4,325 510(k) first actions within 90 days;**
  • Complete 95 percent of PMA "Determination" meetings within 30 days; ** and, 
  • Recognize 20 new or enhanced standards to use in application review **.
  • Utilize Risk management to target inspection coverage for Class II and Class Ill domestic medical device manufacturers at 20 percent of estimated 5,550; and,
  • Utilize Risk management to target inspection coverage for Class II and Class Ill foreign medical device manufacturers at 9 percent of estimated 2,500.
Improving Patient and Consumer Safety

+ $339,000

Mammography Quality Standards (MQSA)

  • The increase of $339,000 will cover inflation to maintain the current level of coverage
  • Ensure at least 97 percent of an estimated 9,200 domestic mammography facilities meet inspection standards, with less than 3 percent with Level I (serious) problems.
  • Expand implementation of the Medsun System to a network of 250 facilities;
  • Maintain inspection and product testing coverage of Radiological Health industry at 10 percent of an estimated 2000; and,
  • Increase by 50 percent the patient population covered by active surveillance of medical product safety by 2008.*

* = Indicates Long-Term Outcome Goal

** = Internal Goal

 

PROGRAM RESOURCE CHANGES

 

Budget Authority

Medical Device Review: + $25,555,000 and + 50 FTE

 

The requested increase in appropriated funding will provide the resources needed to allow FDA to reach the required appropriation level for FY 2005 under the Medical Device User Fee and Modernization Act (MDUFMA).  This increase in budget authority, coupled with the user fee funds collected for the review of medical device applications, will enable FDA to meet the aggressive premarket performance goals committed to under the legislation.  This involves expediting review times which will support our agency wide initiative to make innovative medical technologies available to the public sooner, and helping to reduce the costs of developing safe and effective medical products while maintaining FDA's high standards of consumer protection.  The FY 2005 funds will give FDA the capability to build towards the future so that it can begin meeting the performance commitments for FY 2006 and 2007. The additional funds will be used to:

  • Cover the cost of living increases with $3,900,000 so that FDA can maintain staffing levels and scientific capabilities to meet the demands of an increasing workload and new challenges.  Overall, payroll accounts for over 60 percent of the Agency's total budget. Cost of living increases are necessary to ensure that FDA has adequate staff to meet its Medical Device program goals; 
  • Enhance the IT systems that support the current premarket review process.  This includes modernizing all premarket systems and replacing the outdated and inadequate legacy IMAGE system with the updated IMAGE 2000 scanning system.  The new system will allow FDA to continue to scan documents, such as predicate 510(k)s, and reduce the scanning backlog so that the documents are readily available to FDA's review staff, which will help FDA perform high-quality reviews more rapidly.  FDA will also develop system capabilities to facilitate the submission and acceptance of electronic premarket applications; 
  • Enhance reviewer training and skill maintenance so that FDA reviewers are able to understand and keep pace with the device technologies that are rapidly developing and becoming more complex.  This includes contracting with outside expertise to provide support and training to FDA review staff on a variety of rapidly changing, increasingly complex technological issues, such as innovative new medical procedures and treatments and statistical methods;
  • Employ research and science based activities that provide support critical to the device product approval process;
  • Invest in office and laboratory infrastructure to keep pace with rapid technological and scientific change in the diverse fields of expertise that contribute to effective review and oversight of medical devices;
  • Recruit and contract with subject matter experts to help develop guidance and standards to help industry understand and meet FDA requirements, to prepare and disseminate information on how FDA will regulate emerging technologies, and to help support FDA's role in international harmonization on emerging technologies.  It is necessary for these documents to reflect the complexity of emerging technologies such as nanotechnology, robotics, and demographic developments; 
  • Expand FDA's small business assistance program as required by the FD&C Act.  Approximately 35 percent of the PMAs approved last year were from first time submitters who needed FDA's assistance to understand the statutory and regulatory requirements that must be met, and the scientific, technical, and clinical information requirements that must be provided in an application;
  • Conduct pre-approval inspections for device manufacturers;
  • Enhance policy and guidance document development, emergency response, review management and risk communication for products developed and used to respond to terrorist threats and national security crisis; and,
  • Contract with professional societies to determine staffing and equipment needs for headquarters, centers and field labs, and to plan bio-effects research, and collaborate with Federal agencies and states to develop safe use requirements.

 

User Fees

Medical Device User Fee and Modernization Act (MDUFMA):  + $1,237,000 and     + 17 FTE

 

Sound, risk based review processes are imperative to ensure that medical devices on the market are safe and effective.  To strengthen FDA's medical device review process MDUFMA was authorized in FY 2002 as a multi-year effort to improve the quality and timeliness of the medical device review process.  The user fees supplement the appropriated portion of the medical device review program, and will allow FDA to continue the following efforts:

  • Acquire and train staff to meet a set of aggressive performance goals for expediting the review of medical device applications;
  • Promote public health with major improvements in the review of expedited submissions for medical devices; and,
  • Make major improvements in review performance in areas where fees are collected, while maintaining performance in other areas.

 

Mammography Quality Standards (MQSA): + $339,000

 

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 was signed into law in 1992 to address the public health need for safe and reliable mammography.  The Act required that mammography facilities be certified by October 1994 to be able to remain in operation, and inspected annually to ensure compliance with national quality and safety standards.  The MQSA Program certifies mammography facilities and performs annual inspections to ensure that women have access to safe and effective mammography services.  MQSA was not reauthorized by the 107th Congress because of concerns about the need to improve the skills of physicians reading mammograms and the need for interpretive skills assessment to be added to existing MQSA continuing medical education requirements.  The FDA has been working with congressional staff to address these concerns.  The fees collected pay for the costs of the annual inspections to ensure compliance with national quality standards.  The increase of $339,000 will cover inflation.

 

PROGRAM ASSESSMENT RATING TOOL (PART)

 

In the FY 2004 review, FDA was assessed as five distinct programs (Foods, Human Drugs, Biologics, Veterinary Medicine, and Medical Devices and Radiological Health) and was rated as "results not demonstrated" due to a lack of long-term outcome goals.  To address this concern, long-term outcome goals were developed.    

For FY 2005, the Office of Management and Budget conducted a second program review that treated FDA as a single agency program.  In this review, FDA received a rating of "moderately effective" and score of 77 percent, up from 59 in FY 2004.  This was due to considerable improvements in developing long-term agency-wide outcome goals that will demonstrate its effectiveness and impact on the public health.  FDA also reduced the number of performance goals, and made various management improvements that further streamline its infrastructure while supporting core, mission-critical public health activities. 

The Devices and Radiological Health Program shares in an agency-wide outcome goal of reducing administrative overhead through the reduction of the number of administrative staff.  All of the Agency's outcome goals support the Department's priorities and Administration's initiatives with the intent to improve the health and well-being of the American public. 

 

JUSTIFICATION OF BASE

 

EFFICIENT RISK MANAGEMENT:  THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY BUCK

 

FDA will use science-based risk management in all Agency regulatory activities so that limited resources can provide the most health promotion and protection at the least cost for the public. Efficient risk management efforts for FDA's medical device program are detailed below:

Statutory Device Review Times

Medical devices intended for human use have premarket applications that must be properly processed within statutorily required time frames.  These functions support the Department's priorities to accelerate private sector development of new medical technology.  In addition, MDUFMA commits FDA to significant improvements in device review performance.  The industry is relying on FDA to take a leadership role in regulating a rapidly emerging frontier of medical device technology with timeliness, quality, scientific consistency, and international harmonization.  With the MDUFA appropriated and user fee resources, FDA will be able to:  

  • Reduce the average time for marketing approval for safe and effective new devices and aim to make the greatest reduction in time to market for breakthrough products, in conjunction with the MDUFMA program.  FDA needs to make these improvements in order to successfully implement MDUFMA;
  • Improve the device review program by reducing multi-cycle reviews; and,
  • Work with stakeholders to make premarket applications more complete.

 

Third Party Review Program

 

Third Party 510(k) Reviews are consistent with FDAMA's intent to encourage the use of outside scientific and technical expertise and provide an alternative to FDA review. In addition to being faster than reviews performed exclusively by FDA staff, this option can give manufacturers access to specialized expertise by third parties in areas such as device testing, standards, and foreign regulatory requirements.  FDA will:

  • Conduct activities that encourage industry's use of third party reviews - sixty-five percent of all 510(k)s are eligible for third party review;
  • Maintain FDA's third party web site, which provides information on the Accredited Persons Program; and,
  • Maintain the Third Party Review Board to advise and assess new applicants, reassess existing Accredited Persons that seek to modify their scope of work, and monitor FDA's periodic auditing of their work.

 

Import Monitoring and Inspections

 

FDA must maintain inspection coverage for both domestic and foreign medical device manufacturers.  Although medical devices have become more medically and technologically complex and the device industry is growing at home and abroad, the device and radiological health inspection resources have not kept pace with the growth.  In the area of import monitoring and inspection FDA will:

  • Use risk management to target inspection coverage for Class II and Class III device manufacturers at 20 percent of the estimated 5,550 high-risk device domestic statutory inventory.   This coverage goal does not include any inspections conducted under the "Inspections by Accredited Persons Program"
  • Inspect nine percent of the 2,500 foreign Class II and Class III high-risk statutory inventory firms;
  • Conduct criminal investigations of reported product tampering, counterfeit products, and other fraudulent criminal activities involving FDA regulated products;

 

Seizure and Mandatory Class I Recall

In early March 2002, during a FDA inspection of a medical device company, FDA investigators found evidence that the firm was illegally shipping non-sterile Ob/Gyn and surgical instruments labeled as sterile to accounts throughout the U.S.   Use of these tools without proper sterilization had the potential of causing death or serious injuries such as infection, infertility and miscarriage.  

The firm's owners immediately fled the country after their illegal activity was discovered, thus, it was nearly impossible to determine with any surety who their customers were and what specific devices were involved.  Appropriate action needed to be taken quickly to remove suspect products from the marketplace and warn users of the potential problem.  Through difficult and time consuming record searches a list of over 1,400 potential customers and distributors was assembled, and all distributors of these devices were contacted by telephone to determine what products they distributed. 

FDA issued a Mandatory Recall letter and a Cease and Desist Order, which notified the firm to cease production and distribution of all products involved because of the risk of danger to the public health.  FDA also issued a Safety Alert that was sent to target users of the devices and a Press Release.  

 

  • Conduct emergency operation activities, investigations, and respond to incidents involving FDA regulated products;
  • Review approximately 3,100,000 device import lines for admissibility into domestic commerce;
  • Conduct virtual training for foreign firms to assist in their efforts to voluntarily comply with FDA requirements; and,
  • Conduct import field examinations of imported latex products. 

 

Inspections by Accredited Persons

 

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorizes the Agency to accredit third parties (Accredited Parties or AP) to conduct inspections of eligible manufacturers of Class II and Class III medical devices.  FDA issued guidance to implement the new section 704(g) of the Federal Food, Drug, and Cosmetic Act.  The Inspections by Accredited Persons Program will be conducted independent of third party inspections performed under the current US/EC Mutual Recognition Agreement.  

  • Approximately 48 representatives from 15 AP firms attended an FDA sponsored classroom training program in January 2004.  This training will be followed by individual training inspections conducted with FDA Performance Auditors.  The Accredited Parties will then be ready to conduct independent inspections of FDA regulated establishments; and, 
  • Prepare and publish new draft guidance for establishments participating in the Accredited Parties program.  FDA will not be able to estimate the impact of this new program on FY 2005 inspection coverage until the FDA regulated establishments have applied and been approved to participate in the program. 

 

Human Subject Protection

 

One of the Department's strategic goals is to enhance the capacity and productivity of the Nation's health science research enterprise by strengthening the mechanisms for ensuring the protection of human subjects and the integrity of the research process.  An effective, comprehensive Bioresearch Monitoring program is essential for the expeditious development and approval of safe and effective products and to ensure research subject safety. The Agency continues to leverage scientific capabilities in order to respond and contribute to major breakthroughs in medical device research and technology via continued professional development/ training, and continued stakeholder collaborations.  Some of the new high-risk technologies under active human subject research include:  implantable cardiac defibrillators, in vitro diagnostic devices that help detect/identify biothreat agents, an artificial heart, and drug-eluding stents.  The human subject protection program will:

  • Ensure prompt follow-up to bona fide complaints of research misconduct that may compromise the safety of human research subjects or subvert regulatory review;
  • Conduct Bioresearch Monitoring inspections and data audits in the medical device area to monitor the methods and reporting of FDA regulated research;
  • Inspect clinical investigators to protect the rights and welfare of human and animal subjects involved in FDA regulated research, and to assure the quality and integrity of data submitted to the Agency in support of new product approvals; and,
  • Educate the device research community and maintain professional development of Agency staff to keep pace with clinical research in evolving and breakthrough device technologies.

 

Device Reuse

 

Before enactment of MDUFMA, the regulatory requirements for manufacturers of reprocessed single use devices basically depended upon the class of the device.  Manufacturers of reprocessed class I and II single use devices (the persons who are reprocessing the device) were required to obtain premarket notification clearance (510(k)), unless the device was exempt from 510(k).  Reprocessors of class III devices were required to obtain premarket approval (PMA).  Under the new law, reprocessors of some exempt devices will no longer be exempt from the 510(k) submission requirements but rather will need to submit 510(k)s that include validation data including cleaning and sterilization data, and functional performance information demonstrating that each reprocessed single use device will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the 510(k). Validation data also will be required for many reprocessors of single use devices that are currently the subject of cleared 510(k)s.  Finally, reprocessors of class III devices will need to submit a premarket report (a new type of premarket application).   FDA will:

  • Publish a Federal Register notice identifying semi-critical reprocessed single use devices. These devices are intended to contact intact mucous membranes and not penetrate normally sterile areas of the body, which under the new law will require a 510(k) in order to ensure their substantial equivalence to predicate devices;
  • Enforce the labeling requirement that all reprocessed single use devices must "prominently and conspicuously" bear the statement "Reprocessed device for single use;
  • Publish guidance documents that:  Provide specific information about the types of validation data that should be submitted in a 510(k) for reprocessed single use devices listed in the Federal Register notice and explains how a single use device 510(k) holder may submit the additional data now required by the new law;
  • Inspect up to 100 hospitals annually to evaluate their compliance with premarket clearance requirements and the requirements of the Quality System Regulation; and,
  • Determine whether FDA should regulate the practice of resterilizing opened-but-unused single use devices, based on informed comments from health care professionals and organizations, industry and other interested parties concerned about this practice.

 

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

 

BSE, widely known as "Mad Cow Disease", is a deadly chronic, degenerative disorder affecting the central nervous system.  Feed containing remnants of the slaughtering process, such as the brain and spinal cord, may harbor the agent that causes BSE.  TSE is includes as group of human and animal diseases for which there are no treatment or preventive vaccines and are fatal to humans and animals.  FDA will:

  • Revise Field Investigator's Guidance for Manufacturing Facilities;
  • Maintain a device tracking/animal materials for identifying/tracking devices containing or manufactured from animal-derived source material;
  • Examine ways to prevent the transmission of TSE-related diseases through the use and reuse of medical instruments;
  • Hold public workshops to engage all interested parties in addressing the issue of decontamination of devices exposed to potential TSE disease infectivity; and,
  • Evaluate decontamination procedures for device manufacturing processes, including equipment and facilities and decontamination procedures for medical instruments.

 

International Activities

 

The increase in device imports and the difficulty in inspecting the majority of foreign medical device establishments has resulted in a public health need to fully implement the U.S./European Community (EC) Mutual Recognition Agreement (MRA).  A successful MRA will help reduce the number of foreign firms FDA staff needs to inspect, while relying on FDA inspections conducted by listed European Unions (EU) Conformity Assessment Bodies (CABS).  FDA will:

  • Implement the pilot program on an internationally harmonized format in the review of submissions for device safety and performance.  The pilot is identified as the STED initiative;
  • Develop and maintain information about EU-based medical device manufacturers and provide more information about the status of those manufacturers to help expedite product approval;
  • Maintain FDA's international inspection program to help ensure that all imported FDA regulated products meet the same standards as domestic goods; 
  • Continue FDA's participation as a member of the Global Harmonization Task Force; and,
  • Develop a mechanism for recognizing symbols for use in In Vitro Diagnostic Labeling to allow for harmonization of package inserts in a concise manner.

 

Genetic Testing

 

The vast majority of genetic tests are currently not regulated by FDA.  The Secretary's Advisory Committee on Genetics Testing recommended increased oversight of genetic testing.  FDA participates with the CDC and other agencies to:

  • Develop scientific expertise and regulatory strategies for evolving medical device areas such as genetic testing; and,
  • Collaborate with other DHHS agencies as part of an inter-agency working group and as a participant with the CDC on genetics testing;

 

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 collaborates with CMS to:

  • Categorize commercially marketed in vitro diagnostic test systems; and,
  • Determine which in vitro diagnostic test systems can be placed in the waived category under CLIA.

 

Information Technology

 

  • eRadHealth:  The eRadHealth system will allow manufacturers to submit radiation documentation in electronic format, provide risk management prioritization of data, provide trend analyses, and allow data sharing with States and the public.  It will permit more efficient use of FDA resources and industry-wide corrections of product safety problems; and,
  • Image2000 Document Management System:  The Image2000 Document Management System assists in premarket review and related document-management activities such as archiving and FOI redaction.

 

EMPOWERING CONSUMERS:  IMPROVING HEALTH THROUGH BETTER INFORMATION

Information Technology

 

  • Mammography Program Reporting and Information System (MPRIS): The Mammography Program Reporting and Information System, is a state-of-the-art information management system that supports implementation of MQSA. MPRIS will improve the quality, reliability, integrity, and accessibility of facility certification, inspection, and compliance data.  The system also tracks and monitors the accreditation, certification, inspection, and compliance history of facilities.

 

"FDA & You" Newsletter

Inaugurated the "FDA & YOU" newsletter in the fall 2003, which was targeted to the Secondary Schools population and Health Educators in the school systems.  The newsletter will be published electronically 3 times a year.  The first issue was printed and mailed to 1,600 identified Health Educators as an introduction to the newsletter.  The document dealt primarily with Medical Devices issues:  Toxic Shock Syndrome, Decorative Contact Lenses and Abdominal Muscle Stimulators.  Future issues will incorporate medical product information from other FDA Centers.

 

IMPROVING PATIENT AND CONSUMER SAFETY

 

Another important function of FDA is to identify risks associated with the use of medical products and reduce the occurrence of adverse events.  The enhancement of the adverse events data system and linkages with other health care systems is the first line of defense against medical errors.  The following activities support the Department's initiative to improve the quality of health care services:

  • Increase the enrollment to 250 facilities in the MedSun, a postmarket surveillance system designed to reduce device-related medical errors, serve as an advance warning system, and create a two way communication channel between FDA and its system participants.  This will be accomplished by recruiting a few new facilities and replacing those facilities that choose to rotate out of the system.  FDA will use these facilities to determine the effectiveness of various incentives; the use of facilities as laboratories to obtain specific medical product information; and, pilot various types of feedback to encourage facility reporting;

 

Product Accountability - Medical Product Surveillance Network (MedSun)

Through a report received in March 2003 from a hospital participating in the MedSun program, FDA became aware that they were experiencing a significant increase in the difficulty growing cells for genetic testing from amniotic fluid.  The MedSun program encourages the reporting of "potential for harm" problems that may be associated with medical devices and not just deaths or serious injuries associated with medical products.  This is a significant problem with potentially serious public health implications, since there is a very short time-frame when it is safe to perform amniocentesis, and the procedure itself is not without risk to the patients.  If a lack of cell growth occurs, there may not be time for a second opportunity for a mother to determine if the fetus has possible genetic problems. 

Through FDA investigations it was found that a rubber stopper used in two widely used brands of syringes contained toxic elements, thereby preventing the growth of the cell cultures.  FDA worked with the syringe manufacturers to draft a letter to customers about this potential problem and consulted with the American College of Genetics.  The College sent an alert about rubber toxicity problems to its membership.  Because of the problem that was identified by MedSun, the syringe manufactures are taking steps to improve the product by making changes in the processing of the rubber stoppers. 

 

  • Expand the lab-reporting project to target surveillance, initially piloted in FY 2003 and FY 2004 into all agreeable MedSun sites.  Expansion of the lab-reporting project will allow FDA to evaluate procedures for collecting data on problems with laboratory tests and the feasibility of including hospital laboratory staff;
  • Expand distribution of "FDA Patient Safety News" (FDA PSN), a monthly television news show that communicates FDA's patient safety messages to the health care community.  This major agency-wide effort brings vital information on how to improve the safety of medical products to health professionals across the nation.  FDA PSN can already be seen in about 4,500 hospitals and nursing homes across the U.S. several times each month via medical satellite network broadcasts.  Preliminary results from a recent survey of practitioners who view FDA PSN indicate that 94 percent of respondents used the program's safety recommendations "frequently" (42 percent) or "occasionally" (52 percent);
  • Provide targeted risk management communication about FDA regulated products that pose adverse health risks to consumers and healthcare workers;
  • Provide human factors risk analysis in premarket and postmarket cycles to enhance the identification of risks associated with the use of medical products and to reduce the occurrence of adverse events related to use error;
  • Provide ongoing technical assistance to small medical device manufacturers, and provide accessible; timely feedback to industry, health professionals, and consumers.  This feedback is provided via Device Advice -- the CDRH self-service site for medical device and radiation emitting information, E-mail, Internet Comments and Feedback, links for submitting comments on proposed regulations, and use of automation to provide the public with the latest information;

 

Surveillance and Identification of High Risk Populations

The FDA investigated an increase in the numbers of reports of deaths and serious injuries related to bleeding, and in some cases resulting in death with hemostasis devices that are used to seal off the femoral artery to prevent bleeding from the puncture site after a diagnostic or interventional cardiac catheterization.  FDA published a "Dear Doctor" letter (October 1999) to alert healthcare practitioners to manufacturer warnings and instructions for patient selection and device use.

Through the investigation of hemostasis device adverse events, FDA discovered that women have a much higher reported rate of adverse events.  To further explore the safety and effectiveness of these devices, CDRH entered into collaboration with the American College of Cardiology in use of their National Cardiovascular Data Registry.  This collaboration was funded by the Office of Women's Health and was the first-ever government use of this national registry.  Results of this study were published and FDA provided further educational outreach by presenting these findings at several public and professional meetings.

 

  • Provide consumers with current and reliable information on radiation emitting electronic products, including maintaining the Whole Body Computer Technology Scanning web site; and,
  • Provide guidance to industry on the Alternative Summary Reporting program to eases industry's reporting burden for device-based adverse events.

 

Diabetes, Obesity and Cardiovascular Disease

 

The FDA actively participates in Administration and Department initiatives directed at improving the public health.  The efforts will increase the independence and quality of life of persons with disabilities and long-term care needs.  

In the area of diabetes FDA will:

  • Explore whether more effective but "least burdensome" regulatory mechanisms can be put into place for to assist industry in bringing to market new devices to test, monitor, and administer medications for the management and treatment of diabetes;
  • Partner with the diagnostics industry, health professionals, and diabetics to assure that diagnostics are available that are more accurate, less invasive and easier for patients to use; and,
  • Maintain FDA's Diabetes Information web site, which provides consumers with information about new diabetes findings, new product approvals, upcoming panel meetings, and other current information.

 

Diabetes Web site

FDA's Diabetes web site is the Agency's first disease-specific web site.  The web site contains descriptions of the medical devices, drugs, biologics, and foods that people with diabetes need and use.  It also contains links to more detailed information about specific products, including product labeling. 

FDA developed the Diabetes web site in response to the growing epidemic of diabetes in the United States.  In the year 2000, approximately 17 million people, or 6.2 percent of the population in the United States had diabetes.  In 2002, the total annual economic cost of diabetes was estimated to be $132 billion, or one out of every 10 health care dollars spent in the United States.  From May to August, 2003, the term "diabetes" was among the top 25 search terms entered into the FDA search engine, and in the first year the web site received an average of 4,000 visits per month.  This site is now being used as a model for future disease-specific web sites at FDA.

 

In the area of obesity FDA will:

  • Partner with sponsors on new, promising, investigational weight loss devices, which support the Secretary's goal to reduce the almost 300,000 U.S. deaths a year associated with obesity and overweight.

In the area of cardiovascular disease FDA will:

  • Maintain FDA's Cardiovascular Information web site that is currently being developed.  The site will focus on emerging technology as well as provide information that contributes to better informed consumer participation in the prevention and treatment of cardiovascular disease.

 

MQSA

 

The MQSA program is directed to the certification of mammography facilities and to annual inspections to ensure that they remain in compliance with established quality standards. FDA will:

  • Certify new mammography facilities and recertify one third of the approximately 9,200 existing facilities each year;
  • Analyze and act on inspection results to ensure facility compliance with quality standards;
  • Update and maintain data systems to monitor facility accreditation, certification and compliance status; and,
  • Fund annual inspections for approximately 9 percent of mammography facilities deemed to be governmental entities.  The other 91 percent of the annual facility inspections are funded through user fees.

 

PROTECTING AMERICA FROM TERRORISM

 

FDA continues to monitor, evaluate, and follow up on the public health needs of new medical devices or their use in counter terrorism preparedness and response to regulate them in a manner that best serves the public health.  These activities support the Department's goals to enhance the ability of the Nations health care system to effectively respond to bioterrorism and public health challenges.  FDA will:

  • Develop new diagnostic tests for field and import examinations to help investigators determine if a product has been tampered with or is otherwise tainted;
  • 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, that are 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, and 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, and develop test methods for the Department of Defense (DOD) to test emergency devices for safe use on the battlefield and in civilian emergency care. Expand technical assistance to industry and DOD, expedite review, and expand outreach to civilian emergency medical professionals to give them more information about new devices in their field; and,
  • Conduct research to advance the diagnostic technology and improve techniques for testing decontamination systems; and, assess the in vitro diagnostic market to determine the number and type of test kits 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.

 

Radiological Counterterrorism and Radiation Safety

 

FDA continues monitoring and assessing radiation-emitting products for misuse as weapons, for safe use in detection and deterrence activities, and for the safe use and availability of new and existing radiological products.  FDA also continues preparedness activities for monitoring and assessing radiation contamination of foods and other FDA regulated products.  FDA will:

  • Continue implementation of the Emergency Counterterrorism Preparedness and Response Plan for radiation;
  • Assist the Transportation Security Administration (TSA), U.S. Customs, and the National Institute for Occupational Safety and Health (NIOSH) to assure worker safety during use of non-intrusive search products which emit x-rays;

 

National Evaluation of X-ray Trends (NEXT)

The Nationwide Evaluation of X-ray Trends program is a successful and world-recognized collaboration of FDA with the Conference of Radiation Control Program Directors (CRCPD), the umbrella organization of state radiation control agencies, to monitor the radiation doses patients receive during diagnostic x-ray exams.  NEXT provides the radiological community with important technical indicators of diagnostic x-ray practice and addresses specific concerns from both the private and professional sectors.  Each year the NEXT program selects a particular radiological examination for study and captures radiation exposure data from a nationally representative sample of U.S. clinical facilities.  The program is currently evaluating computed tomography, a procedure that administers significantly higher doses to patients than standard x-ray film procedures.  

NEXT continues to be recognized as a national resource. NEXT data were used in the development of the CRCPD Patient Exposure and Dose Guide -- 2003 (CRCPD Publication E-03-2). Additionally, at the urging of the American College of Radiology, the American Association of Physicists in Medicine is relying on NEXT data to develop reference exposure values for common diagnostic exams. 

 

  • Coordinate with the Nuclear Regulatory Commission on laser safety of power plant security and all emergency preparedness exercises;
  • Provide assistance to Customs and other agencies on safe use of x-ray cargo screening and electromagnetic personnel screening products;
  • Increase field surveillance of x-ray security screening products subject to the FDA cabinet x-ray standard;
  • Develop an electronic reporting system to reduce industry reporting time and FDA review time, and provide sufficient radiation data on security products and potential weapons to assure safety of workers and the public and to respond quickly in a terrorist event;
  • Develop a mandatory standard for x-ray personnel security screening equipment based on the voluntary standard prepared by FDA, State and industry representatives;
  • Develop a radiation safety consensus standard for cargo screening and other new non-intrusive search products that emit x-rays, neutrons or gamma rays; and,
  • Inspect and test 10 percent of the radiological health industry. Advances in new technologies and expansion of overseas manufacturing facilities increase the likelihood that new products will not meet performance standards or standards may not exist for the new technologies.   FDA continues to detect increasing numbers of electronic product radiation emissions that far exceed radiation safety standards.

 

STRONG FDA

 

A strong FDA will ensure a world-class professional workforce, effective and efficient operations, and adequate resources to accomplish the mission of FDA.  FDA's performance goals under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) recognize that FDA needs to build infrastructure, hire and train new staff, and take other steps to lay the groundwork for success.  FDA will:

  • Implement the goals accompanying the authorization of MDUFMA and set forth in the commitment letters from Secretary Thompson that addresses FDA need to build up its infrastructure to have a successful review program; 
  • Train new and current staff to keep their skills current as medical device technology evolves;
  • Increase access to outside experts to help improve the quality of our work; and,
  • Support the President's Management Agenda and FDA's competitive sourcing A-76 effort by performing cost comparison studies for commercially identified functions.

 

SELECTED FY 2003 ACCOMPLISHMENTS

 

THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY BUCK

 

Significant Achievements:

  • Met all the MDUFMA statutory deadlines for FY 2003, and maintained or improved device review performance in areas not covered by official performance goals;
  • Hired 67 new employees including scientists, engineers, project managers, statisticians, medical officers, review supervisors, and administrative staff for MDUFMA implementation. Since most of these employees were hired very late in the fiscal year, the impact on performance outputs will not be felt until FY 2004;
  • Accelerated training of new and existing staff on the new guidance required to implement MDUFMA, and developed training plans to increase clinical and technical training in FY 2004;
  • Expanded the use of contractors to allow FDA to meet nonrecurring review workloads, strengthen expertise, and improve the IT infrastructure;
  • Developed 24 Federal Register notices and guidance documents relating to MDUFMA implementation, and published an internal "Blue Book" memo to provide guidance to FDA staff; and,
  • Increased outreach efforts to stakeholders explaining the new requirements and provisions of MDUFMA. 

FDA will use science-based risk management in all Agency regulatory activities so that the Agency's limited resources can provide the most health promotion and protection at the least cost for the public.  Premarket review accomplishments include:

  • Met the performance cited in the MDUFMA regulation for FY 2003, and continued to develop procedures and documents to implement new premarket review policies; 
  • Initiated a Total Product Life Cycle cooperative project to determine the best way to incorporate epidemiology expertise into potential postmarket investigations and product specific postmarket plans; and,
  • Improved the review process by developing a Device Evaluation Division Tracking System to increase to perform ad hoc queries and enter data, in addition to giving management a view of Division workloads to assess review performance.

Significant medical device approvals/clearances and accomplishments include:

  • Cleared a diagnostic kit that sharply reduces the time needed to test patients for the West Nile Virus infection.  This test only takes hours with results available the same day, while results for the current West Nile Virus test usually take up to two weeks.  Over 7,000 human cases of West Nile Virus have already been reported to the CDC for 2003 and early treatment is important for full recovery;  
  • Approved the first left ventricular assist device as a long term implant, and in patients with end stage ventricular failure who are not eligible for cardiac transplantation;
  • Approved a limb salvage system for children with knee replacements that lose growth in the affected limb.  The spring expansion technology in the device eliminates or reduces the need for surgery to expand a prosthesis as the child grows; and,
  • Approved a new indoor/outdoor power stair climbing wheelchair that allows greater freedom for its users since it can be used on smooth services and inclines at home and in the community, over obstacles, with uneven terrain, curbs, grass, gravel, and other soft surfaces.Wheelchair

Third Party Review Program accomplishments include:

  • Using the third party review program for 510(k) submissions.  In FY 2003, FDA received 190 applications, a 50 percent increase over the industry's use of the program in FY 2002. This contributed to a more rapid market entry for products, since they receive marketing clearance nearly 30 percent faster than comparable 510(k)s reviewed entirely by FDA. 

Import monitoring and inspections accomplishments include:

  • Exceeded the FY 2003 performance target of 20 percent coverage by inspecting 26 percent (1,428) of the registered domestic Class II and Class III medical device manufacturers;
  • Met the FY 2003 performance target of inspecting 9 percent (225) of the registered foreign Class II and Class III medical device manufacturers; and,
  • Conducted an Internet review to identify any manufacturers, distributors, and Internet marketers making misleading protection and prevention claims about severe acute respiratory syndrome. The review focused on infectious control devices, and FDA worked with the Federal Trade Commission to warn web site operators, manufacturers and distributors about making deceptive claims.

 

FDA Investigation of 70 Deaths from Contaminated Kidney Hemodialyzers

A public health crisis was successfully resolved because of the coordinated efforts of the FDA and industry to conduct a voluntary class 1 recall of 2.4 million hemodialyzers.  In October 2001, CDRH received reports of several patient deaths at kidney hemodialysis facilities in the U.S. and many more fatalities in Europe, Asia and South America.  

The common link proved to be three models of hemodialyzers manufactured by a U.S. based company at their European facility.  Analysis confirmed the presence of a chemical fluid contaminant that was used during a step in the manufacturing process in some of the recalled dialyzers.  The heat of the patient's blood during hemodialysis caused the residual chemical to change from a fluid to a gas, causing an air embolism in the lungs, leading to death.  Due to the problem in the manufacturing process the facilities in Sweden and Florida were permanently closed by the manufacturer.

 

Inspections by accredited persons accomplishments include:

  • Accredited third parties to conduct inspections of eligible manufacturers of Class II and Class III medical devices, which will help FDA focus its limited resources on higher-risk inspections and give medical device firms that operate in global markets an opportunity to more efficiently schedule multiple inspections. 

Human subject protection accomplishments include:

  • Accomplished 364 or 123 percent, which is 69 more than the 295 target inspections planned in FY 2003; 
  • Initiated an inspection program of clinical investigators, sponsors and institutional review boards to assess human subject protection measures in device clinical studies involving vulnerable or exploitable populations.  Early inspection results indicate a higher compliance rate in studies involving vulnerable or exploitable populations compared to the overall human subject protection program; 
  • Halted research associated with vulnerable/exploitable populations due to unacceptable risk to patients.   Some examples of suspended research include: two silicone breast implant studies -- women with breast reconstruction issues; device study for plugging holes in babies hearts -- pediatric population; study of a vertical expandable prosthetic titanium rib -- pediatric population; study of a deep brain stimulation lead -- Parkinson patients; and a study of a stent graft device -- heart aneurysm patients; and,
  • Fined an ophthalmologist and eye care center a total of $1.1 million and disqualified them from conducting further clinical studies, for 175 violations associated with a study of a laser system built to treat nearsightedness. 

Device reuse accomplishments:

  • Complied with all the MDUFMA requirements relating to reprocessed single-use devices (SUDs);
  • Identified and published the types of reprocessed single-use devices for which 510(k)s will be required, which triggered the MDUFMA time frame for submission of validation data for devices on the list that already are subject to a cleared 510(k);
  • Published a list of critical reprocessed single-use devices whose exemption from premarket notification was revoked and requires validation data;
  • Issued guidance to help manufacturers of reprocessed single-use devices understand and comply with the new premarket requirements;
  • Revised the MedWatch form to reflect additional information for tracking problems associated with reused devices;
  • Issued a Consent Decree of Permanent Injunction to prevent a manufacturer from shipping violative, and potentially harmful reprocessed single-use devices to hospitals; and,
  • Continued to inspect hospitals that reprocess SUDs to obtain more information about the frequency of hospital reprocessing.  Based on information available to date, most hospital reprocessing has now shifted to third party sources.

Transmissible Spongiform Encephalopathy (TSE) accomplishments include:

  • Participated in the interagency TSE Advisory Committee meeting that focused on decontamination of medical devices and equipment used in manufacturing, to gain more knowledge about the decontamination and inactivation of TSEs for medical devices.

International accomplishments include:

  • Developed the in vitro diagnostic annex to the international standard on risk management;
  • Trained and evaluated the European Union Conformance Assessment Body (CAB) auditors through the joint inspection program, and established a team to conduct on-site evaluations of United States CABs; and,
  • Initiated a one-year Summary Technical Documentation pilot to assess a proposed internationally harmonized format and content for PMA and 510(k) submissions, to help determine if the harmonized format is a viable alternative to current premarket submission formats and whether the program should be continued or expanded.

Clinical Laboratory Improvement Amendments (CLIA):

Congress passed CLIA in 1988 establishing quality standards for all laboratory testing.  Published in 1992, the regulations established criteria for categorizing tests on the basis of complexity for moderate and high tests.  CLIA accomplishments include:

  • Received the delegation of authority for rule making for the CLIA complexity categorization program (includes authority for waiver determinations), which previously resided with the Centers for Medicare and Medicaid Services.  The shift in authority clarifies the process for obtaining waivers for eligible diagnostic products;
  • Waived the need for conventional testing under CLIA regulations for the first rapid HIV antibody test.  This test can be administered in a wide variety of outreach settings, including bars, with results available within 1 hour or less with 99.6 percent accuracy.  Waiver testing will allow many previously undetected HIV cases to be identified, resulting in earlier medical treatment and attention; and,
  • Waived two respiratory virus tests for use in pediatric patients to evaluate lower respiratory tract infections, making these tests accessible for point-of-care testing in a wide variety of physician office labs, resulting in better triage of patients.

 

EMPOWERING CONSUMERS:  IMPROVING HEALTH THROUGH BETTER INFORMATION

 

CDRH communicates a broad spectrum of public health information to a wide variety of stakeholders ranging from consumers to manufacturers to healthcare providers.  This information will enable consumers to make better informed decisions by weighing the benefits and risks of FDA-regulated products.  These accomplishments include:

  • Created a new web page for the Office of In Vitro Diagnostics, including information on regulatory activities, new items, and laboratory safety tips.  The web site also offers access to databases that provide information on products cleared for over-the-counter use, FDA review summaries for cleared IVDs, and recent compliance actions;
  • Provided information packet to 16,000 secondary school health educators, which included a letter, the "FDA and You" web-based newsletter, and a Contacts Listing brochure.  The first issue of the newsletter (Fall 2003) contained information about toxic shock syndrome and tampons, improper use of decorative contact lenses, CDRH's bionic skeleton named "Yorick", and abdominal muscle stimulators;
  • Developed and distributed a Hospital Bed Safety videotape to nursing homes and caregivers, to educate healthcare professionals about the dangers associated with patient entrapment in hospital beds.  FDA also developed a web site on this topic because since 1990, FDA has received 102 adverse event reports of head and body entrapment incidents involving hospital bed side rails, in hospitals, long-term care facilities, and private homes; and,
  • Met with manufacturers of infusion pumps to educate them about the importance of human factors such as clear, simple user instructions, inform them about the FDA Human Factors program, and to provide the regulatory status of human factors.   Infusion pumps are used in home care as well as in medical facilities and remain an important area of concern to CDRH because numerous safety and use problems associated with these devices are tied directly to human factors.

 

Whole Body CT Screening Web Site -- Better informed Consumers

Whole Body CT Screening is being touted as a new service for health conscious people to peer inside their bodies and receive early warnings of cancer, cardiac disease and other abnormalities. These claims, are not proven, and caused considerable confusion and misinformation among the general public.  FDA established the Whole Body CT Screening web site to inform consumers with factual information about the benefits of CT diagnostic imaging and to point out the lack of scientific evidence supporting the use of CT as a whole body screening tool.  Prior to finalizing the site and bringing it online, the Agency obtained extensive extramural review of the site content. 

The resulting web site is a balanced, credible, and reader-friendly discussion of the issues.  Since the site went online in April 2002, the site became very popular, with over 125 internet sites linking to or containing FDA's whole body CT screening web address.  Recognizing the importance of the issue health related organizations, developed their own organizational policy, or in some cases, States issued health advisories discouraging whole body CT screening.  When whole body CT screening first was being marketed, FDA was concerned that screening "entrepreneurs" would proliferate across the U.S., in fact, this has not been the case and many of these facilities have since closed.  FDA has become a major influence in voicing concern about the yet unproven benefits of whole body CT screening for asymptomatic persons.

 

IMPROVING PATIENT AND CONSUMER SAFETY

 

One of FDA's strategic goals is to identify risks associated with the use of medical products and reduce the occurrence of adverse events.  CDRH's adverse event data system and linkage with other heath care systems is the first line of defense against medical errors.  Patient safety accomplishments include: 

  • Expanded the CDRH Medical Device Surveillance Network (MedSun) to include representative laboratories in a pilot program called "LabSun".  The goal of the pilot is to determine if this form of active surveillance can be used to supplement the current surveillance data obtained through the current Medical Device Reporting system;
  • Successfully used the Medical Device Reporting system and a MedSun facility to withdraw a risky product from the market.  Because of the collaboration between the clinical community and FDA to improve patient safety, FDA became aware of key information about the product's problems.  This information led to positive discussions with the product manufacturer, resulting in the product's removal; 
  • Contracted with the Institute of Medicine to initiate a postmarket surveillance study for pediatric products, focusing on various components of postmarket surveillance including:  study committee members; role of expert consultants; role of implants; pediatric safety issues; and guidance for premarket considerations; and,
  • Conducted a risk/benefit assessment of alternatives to dental amalgams, so that FDA can respond to public concerns about the safety of dental amalgams.

 

Decorative Contact Lenses

Through information collected through FDA's adverse event reporting system and other complaints received throughout the United States, FDA issued warnings to the public about the improper use of decorative contact lenses.  These contact lenses were being actively marketed and distributed through beauty supply stores, flea markets, convenience stores, beach shops, gas stations, and various Web sites, and did not have proper labeling about the risks and proper instructions for safe use.

FDA issued a health notice to consumers outlining the serious risks associated with using decorated contact lenses without appropriate involvement from an eye care professional.  These risks include corneal ulcers that can progress rapidly and, if untreated, lead to an infection of the eye.  Uncontrolled infection can lead to corneal scarring, and in some cases blindness and eye loss.   Other risks included infection, swelling, allergic reaction, corneal abrasion due to poor lens fit, and reduced visual functions including sharpness, and contrast sensitivity. 

FDA also issued a warning letter to one firm, and wrote to major internet sites alerting them to the public health risks and encouraging them to prevent improper online sales.  FDA also issued an import alert to prevent the distribution of contact lenses that did not have the appropriate eye care professional involvement.

 

 

Diabetes, obesity, and cardiovascular disease accomplishments include:

  • Maintained and continued to develop the FDA disease specific web page on diabetes that combines information from all FDA Centers into one location for easy access and usability.  The web site records approximately 4,000 visits per month, and many government and consumer web sites link directly to it.  This site is now being used as a model for future disease-specific web sites at FDA;
  • Cleared the first device for diabetics that integrates a glucose meter and an insulin pump with a dose calculator into one device, making it more convenient for people to manage their diabetes, resulting in fewer dosing errors;
  • Cleared the first over-the-counter test that measures glycated hemoglobin to help people with diabetes monitor how well they are managing their disease.  This test, which was previously used only in medical facilities, will make it easier for many patients to monitor long-term control over their blood glucose levels, complementing the information obtained from daily finger stick blood glucose tests;
  • Closely monitored insulin infusion pumps, which are being widely used by diabetics because they control blood glucose better than traditional insulin injections, and are less burdensome to the user.  There has been an increase in serious hypo and hyperglycemic events caused by faulty programmable insulin pumps.  FDA has been conducting inspections of all foreign and domestic manufacturers, leading to several recalls, a Safety Alert, numerous warning letters, and an import alert; and
  • Issued a public health web notification about adverse events associated with a coronary stent.  FDA was alerted to almost 300 reports of sub-acute thrombosis through the Medical Device Reporting (MDR) system, with many associated with patient death or patient injury requiring medical or surgical intervention.
Picture of a Stint








Coronary Stint

Science and standards accomplishments include:

  • Developed and promoted the use of standards for manufacturing safer and more effective medical products and to enhance the quality of regulatory decision making.  In FY 2003, FDA recognized 25 new standards for a cumulative total of 618; and,
  • Assisted in the development of a final performance testing standard for oxygen regulators through the American Society for Testing and Materials (ASTM).  This effort addressed the increasing number of reported fires and explosions that were occurring in oxygen regulators, resulting in significant burns and a death.  ASTM, NASA, FDA, and the industry all worked together to develop a test method that would identify poor designs that existing standards could not identify.

MQSA accomplishments include:

  • Conducted inspections of mammography facilities and found that more than 97 percent of the facilities met the MQSA inspection standards, with only 2 percent of the facilities showing Level 1 (most serious) problems. This is the fifth consecutive year of achieving this high standard;
  • Incorporated MQSA national facility inspection data on the MQSA Facility Scorecard web page.  This web page provides information about facility performance on MQSA standards, gives facilities the opportunity to compare themselves to the rest of the nation, and provides a mechanism for facilities to contact FDA regarding the scorecard and other MQSA issues; and,
  • Implemented a new enforcement strategy that addresses how facilities should respond to serious (Level 1) inspection observations, and what follow-up actions FDA may take if facilities do not correct the problems. 

 

PROTECTING AMERICA FROM TERRORISM

 

FDA continues to work with other Federal, state, and local government agencies and the military to strengthen its capability to identify, prepare for, and respond to terrorist threats and incidents.   In FY 2003, FDA's Device and Radiological Health program:  Developed and implemented an Emergency Medical Device Shortage Plan that allows quick identification of device manufacturers and distributors, which gives FDA the ability to predict and manage potential device shortages.  This will help the Agency identify available inventories and locations of limited critical medical devices such as rubber gloves or ventilators, and liaison with the medical products supply chain distribution network to facilitate transport of devices;

  • Participated in the government-wide TOP OFF2 exercise which tested FDA's communication capabilities and interaction with other Departments of the Federal Government and State/Local components.  FDA contributed:  radiological health expertise relating to the effects and possible contamination from the dirty bomb released in Seattle; information on the availability of respirators, gowns, gloves, masks, and other requested or anticipated medical devices; expertise to respond to inquiries regarding diagnosis and treatment products for the plague; and information for the user community on applicable devices for safety and protection;
  • Updated Continuity of Operations emergency response plans, in conjunction with HHS and FDA, to identify the essential functions that need to be maintained to monitor and respond to a terrorist event or emergency situation.   The Agency also conducted emergency response training to ensure that FDA public health emergency responders were trained in emergency standard operating procedures;
  • Finalized the Emergency Preparedness and Radiological Health Response plan and established a Corporate Communications Center to conduct emergency operations related to medical devices and radiological health products;
  • Participated in several interagency working groups related to the use of in vitro diagnostics for the identification of biological threat agents;
  • Classified preamendment laboratory diagnostic reagents for the identification of B. anthracis and Yersinia pestis as Class II devices with special controls and restricted use based on the FDA's Microbiology Devices Panel recommendation.  These devices were not included when preamendment devices classified beginning in the late 1970s;
  • Evaluated the safety and effectiveness of diagnostic tests that identify biothreat agents as well as other diagnostic and therapeutic devices being developed to address such threats such as ultraviolet purifiers and sterilizers for use in decontamination of surfaces and products; and,
  • Developed a Notice of Proposed Rule Making to propose an amendment to the exception from informed consent requirements (21CFR 50.23) to apply in certain circumstances involving the use of investigational in vitro diagnostic devices that identify chemical, biological, radiological, or nuclear agents. 

 

Radiological Counterterrorism and Radiation Safety

 

  • Worked with government security agencies and standards organizations to develop a standard for safe security screening devices and to address safety concerns regarding the practice of exposing people to x-rays for non-medical purposes;
  • Entered into a Consent Decree of Injunction with a company to prevent the manufacture and distribution of radiation therapy medical devices used for cancer treatment, that contributed to 28 patients receiving excessive amounts of radiation that led to several patient deaths;
  • Partnered with state-level radiological health agencies to communicate radiological health issues directly to the end-user.  Worked closely with the National Evaluation of X-ray Trends program, and the Conference of Radiation Control Program Directors to monitor the radiation doses patients receive during diagnostic x-ray exams;
  • Conducted a two-week Diagnostic X-ray Inspectors training course for state and FDA inspectors, participating in agreements with the Agency to conduct diagnostic x-ray field survey tests.  This allows the Agency to maintain an adequate number of qualified FDA and state x-ray inspectors in the field;
  • Assessed civil money penalties of $475,000 against a firm manufacturing computer monitors and television receivers that continued to import products into the United States while its quality control and testing program was disapproved by FDA; and,
  • Developed an electronic adverse event reporting system (eRadHealth) for radiological health manufacturers, to automate the review, analysis and management of the 19,000 radiological health safety product reports received each year.  This system provides FDA, the States, and other Federal agencies with the information necessary to make good risk management decisions, and gives health care professionals and consumers the information needed to make informed choices.

 

STRONG FDA

 

A strong FDA will ensure a world-class professional workforce, effective and efficient operations, and adequate resources to accomplish the mission of FDA.  FDA took many steps during the year to attract, develop and retain a highly skilled and diverse workforce.  Specific accomplishments include:

  • Piloted a "Mentoring for Excellence Program" with five new training courses, to develop a skilled and talented pool of managers whose competencies align with the Center's strategic plan;
  • Created the "Science Leadership Education Program", which is a joint educational venture between FDA, Georgetown University and Virginia Polytechnic Institute, designed to encourage continual learning;
  • Developed the "CDRH Medical Device Fellowship Program" to provide an opportunity for health professionals in the scientific community to participate in the FDA medical device regulatory process, share their knowledge and experience with medical devices with FDA, and increase the range and depth of collaborations; and,
  • Created the Office of In Vitro Diagnostic Device Evaluation and Safety by combining premarket and postmarket regulation of in vitro diagnostic devices into a single organization unit.  This reorganization allows internal and external stakeholders to contact one organization to get information, promotes the CDRH strategic goal of "total product life cycle", and leverages resources to create, share, and use knowledge.

 

Devices and Radiological Health

Program Activity Data

 

Program Workload and Outputs FY 2003
Actual
FY 2004
Conference
FY 2005
Estimate 3/
PMAs Received (includes PDPs & Expedited PMAs)

54

50

50

PMAs Approved

31

43

43

Average Time (# of FDA days)

246

275

250

Expedited PMAs received (# of FDA days)

3

9

9

Expedited PMA Decision Time MDUFMA Goal (# of FDA days)

NA

NA

70% in 300

PMA First Actions MDUFMA goal

NA

NA

75% in 180

Total PMA Actions1/

198

250

250

 
Humanitarian Device Exemptions Received

10

6

6

Humanitarian Device Exemptions Approved

2

5

5

Average FDA Review Time (FDA days approval)

152

120

110

 
PMA Supplements Received

669

625

650

PMA Supplements Approved

494

525

530

Average Review Time (# of FDA days)

85

100

95

 Review Time MDUFMA Goal (# of FDA days)

NA

NA

75% in 180

 
PMA Supplement Panel Tracks2/ (Received/Approved)

6/11

20/15

20/15

 
 
 
 
510(k)s Received (includes Trad., Special, Abbrev., 3rd party

4,247

4,325

4,325

510(k)s Completed (All Decisions)

4,132

4,200

4,200

Average Review Time (# of FDA days)

76

80

75

FDA Decision Time MDUFMA Goal (# of FDA days)

NA

NA

75% in 90

 
Investigational Device Exemptions Received

242

315

315

Investigational Device Exemptions Total Decisions

246

315

315

Average Review Time (# of FDA days-approval)

27

30

30

Investigational Device Exemptions  Supplements Received

4,415

5,200

5,200

IDE Supplements (Approved/Total Decisions)

4,424

5,200

5,200

Avg FDA Review Time (# of FDA days)

19

22

21

 
Total Standards Recognized for Application Review 618 700 720
Note:  FY 2004 estimates are based the President's Budget Request.
1/Includes filing decisions, review determinations, and approval decisions.
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/ FDA is committed to meeting the performance goals cited in the MDUFMA legislation.  The user fee funds, 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. 
       

 

Field Devices and Radiological Health

Program Activity Data

 

PROGRAM OUTPUTS-DOMESTIC INSPECTIONS FY 2003
Actuals
FY 2004
Conference
FY 2005
Estimate
Bioresearch Monitoring Inspections

357

275

300

Inspections Pre-Approval

146

125

150

GMP Inspections (Levels I, II, and III)
(includes Accredited Persons Inspections)

1,680

1,680

1,680

Total Domestic Inspections: Non-MQSA

2,183

2,080

2,130

 
 
 
 
Inspections (MQSA) FDA Domestic (non-VHA)

361

360

360

Inspections (MQSA) FDA Domestic (VHA)

34

35

35

Inspections (MQSA) by State Contract 4/

7,804

7,700

7,700

Inspections (MQSA) by State non-Contract

513

545

545

Total Domestic MQSA

8,712

8,640

8,640

 
 
 
 
State Contract Devices Funding

$1,140,000

$1,350,000

$1,350,000

State Contract Mammography Funding

$9,114,000

$9,888,000

$9,888,000

 
 
 
 
Domestic Radiological Health Inspections

129

200

200

Domestic Field Exams/Tests

1,454

1,500

1,500

Domestic Lab Samples Analyzed

146

310

310

 
 
 
 
PROGRAM OUTPUTS-IMPORT/FOREIGN INSPECTIONS
 
 
 
Foreign Bioresearch Monitoring Inspections

7

20

20

Foreign Pre-Approval Inspections

45

60

60

Foreign GMP Inspections

203

230

230

Foreign MQSA Inspections

10

15

15

Foreign Radiological Health Inspections

24

40

40

Total Foreign FDA Inspections

289

365

365

 
 
 
 
Import Field Exams/Tests

4,810

1,900

1,900

Import Laboratory Samples Analyzed

1,397

1,680

1,680

Import Physical Exam Subtotal

6,207

3,580

3,580

 
 
 
 
Import Line Entry Decisions

2,236,983

2,600,000

3,100,000

Percent Physical Exams of Import Entries

0.28%

0.14%

0.12%

4/ The estimate of the total number of Inspections (MQSA) performed by State Contract (non-federal, non-VHA, and non-SAC facilities) reflects a decrease in the actual facility inventory and hence a slight reduction in the number of inspections.

 

<< Return to FY 2005 Budget Proposal