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OCD FY2004 Part 4. Risk Based Management Practices - CDRH Strategic Goal: Public Health Impact

mCDRH Clinical Laboratory Improvement Amendments Activities

The Department of Health and Human Services delegated the authority to implement the Clinical Laboratory Improvement Amendments’ (CLIA’s) complexity categorization provisions, as they apply to commercially available tests, to FDA in a delegation published in the Federal Register on April 27, 2004. Implementing and interpreting CLIA's complexity categorization provisions involves activities necessary to determine whether laboratory tests will be categorized as waived, moderate complexity, or high complexity tests. Based on this new authority, CDRH’s OIVD established quarterly tri-agency meetings with the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) to coordinate activities of the various agencies that affect aspects of the CLIA program that are delegated to each agency. Additionally, OIVD, with help from CDC, CMS and the HHS Advisory Committee for CLIA, began the process of clarifying what products satisfy CLIA.

Human Subject Protection

One of HHS’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. To protect human subjects and the integrity of the research process, in FY 04 the Division of Bioresearch Monitoring’s Research Misconduct program halted research associated with certain high risk investigational devices such as hip and knee implants for the elderly, devices for plugging holes in pediatric patients' hearts, lasers used for surgical procedures in the eye, coronary stents, ultrasound surgical devices for uterine fibroids, and diagnostic kits for infectious disease. Some of these actions are discussed in more detail below.

Application Integrity Policy

Application Integrity Policy is applied to firms that have engaged in wrongful acts that raise significant questions regarding data reliability or human subject protection in research or marketing applications submitted for review. CDRH stops substantive scientific review of pending applications and may ask the firm to withdraw any approved applications until violations have been satisfactorily corrected and procedures and controls that will prevent further recurrence of these violations have been implemented. In FY 04, CDRH placed three firms on FDA’s Application Integrity Policy List. As a result, one firm withdrew six suspect applications for orthopedic prostheses; CDRH stopped another firm’s research on a pediatric device; and CDRH suspended review of a pending application for an infectious disease diagnostic device.

Early Intervention Program

CDRH initiated a program that focused on real time inspections, those conducted during the research phase of an investigational device exemption (IDE), for active device research involving exploitable populations such as pediatric and physically challenged subjects, as well as studies involving novel or breakthrough technologies. Normally bioresearch monitoring inspections are done after the research has been conducted and the data is submitted to CDRH with a premarket approval application. Under this initiative, the inspection assignments are issued as the research is being conducted, so that adjustments can be made during the research rather than after, to help prevent improper research activities from harming patients and impeding the process for advancing medical technology.

Unapproved Pediatric Device Removed from the Market

In FY 04, CDRH stopped research on a pediatric device to treat a congenital heart defect when inspectional findings disclosed that the sponsoring firm had failed to report two deaths that occurred with the device before CDRH had approved it for use in research. CDRH also found that several physicians had implanted infants and children with the device without CDRH or institutional review board (IRB) approval and without informing the children’s families that they had used an investigational device. While use of the unapproved device could negate the need for open heart surgery in some cases, not all of the clinical outcomes were positive. The investigation prompted the hospital's IRB to conduct their own internal investigation, resulting in dismissal of two participating doctors and a senior administrator, and termination of the research. Follow up inspection of the device manufacturer revealed other physicians who had been shipped the unapproved device. Appropriate CDRH regulatory and administrative response resulted in an unapproved device being removed from the market, and notification and follow-up for pediatric patients. Further research of this unapproved device will be conducted under a carefully designed, CDRH-IRB approved clinical trial.

Import Monitoring and Inspections

During FY 04, CDRH continued to enhance risk-based management of the import monitoring and inspection program in order to assure the safety of medical products manufactured for use by American consumers.

Management of Inspection and Enforcement Actions

CDRH created and implemented a risk-based management program for inspection and enforcement actions which will improve the decisions CDRH makes in regulating and monitoring the medical device industry. The new program will impact how CDRH prioritizes inspections and identifies and prioritizes other types of regulatory activities, such as device recalls, that present the greatest risk to public health.

Risk Assessment Criteria Developed

As part of the new risk-based management program, CDRH used the ISO standards’ definition of risk as a foundation in developing its risk assessment criteria. This definition shows risk to be a combination of the probability of occurrence of harm and the severity of that harm. Harm is a negative effect on a person or person's health due to an unsafe or ineffective device, reduction in a device's safety/effectiveness, clinical benefit, fitness for use, improper use, or quality. CDRH’s new risk assessment criteria help focus our limited field resources on those medical devices and manufacturers that present the greatest risk to public health.

Work Planning Prioritization

CDRH developed a prioritization process proposal for work planning using Center-wide risk assessment criteria, and implemented an inclusive risk-based inspection work plan process. This process ensures that all Center program offices are afforded an opportunity to provide input into prioritizing special emphasis inspections;

Division of Risk Management Operations

The Division of Risk Management Operations was created within CDRH’s Office of Compliance to focus more attention on risk management activities and support. The new division includes a Risk Management and Analysis Branch that focuses on collecting data from systems already available but not linked, analyzing and presenting findings that can be used in the risk-based decision making process. In addition, the Branch is responsible for monitoring program outcomes, analyzing current medical device compliance programs and identifying the need for more effective medical device compliance programs.

Reduced Inspection Delays

This fiscal year, we reduced premarket inspection delays, from 53% in FY03 to 15%, despite foreign inspection travel restrictions. This was achieved through improved communication and coordination with ORA management including reporting current status of inspection assignments for early intervention of problem areas, awareness of mandated timelines, and the assignment of PMA coordinators in the district offices.

Inspections for Reprocessed SUDs

In FY 04 we inspected over 100 randomly identified U.S. hospitals to determine their compliance with the Quality System regulation for the reprocessing of single use devices. The inspections found no hospitals currently reprocessing SUDs.

Radiological Health

Radiological Health Consolidation

The CDRH Radiological Health Program reorganized effective September 30, 2004. Sixteen staff members, who conducted radiological health activities within the Office of Compliance, were reassigned to OCER. The Electronic Products Branch and the Diagnostic Devices Branch are now located within OCER’s Division of Mammography Quality and Radiation Programs.

This reorganization was the outcome of a 2-year review of CDRH’s Radiological Health Program. The review was summarized in a report from the facilitating contractor and a number of CDRH radiological health staff. The report indicated that the current problems of public health significance in the radiological health arena are largely problems of use (rather than problems with the equipment itself) and these problems are best addressed by emphasizing user and public education, a principal function of OCER. A core planning team has been charged with the task of developing a plan for the CDRH Radiological Health Program by mid FY 05.

Radiological Health Program Accomplishments

CDRH continued working with government security agencies and standards organizations to provide technical and regulatory consultation on equipment, standards, and research related to x-ray security screening devices.

In FY 04 we:

  • Updated the “FDA Emergency Counterterrorism Preparedness and Response Plan for Radiation”, identifying key personnel and processes for FDA to follow when responding to a national radiological emergency.
  • 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 (NEXT) program and the Conference of Radiation Control Program Directors (CRCPD) to monitor the radiation doses received by patients during diagnostic x-ray exams. Published a paper in Radiology on the 1995 NEXT Abdomen and Lumbosacral Spine survey.
  • Conducted a two-week Diagnostic X-ray Inspectors Training Course for state and FDA inspectors. This course is the primary tool by which CDRH provides training to state inspectors participating in agreements with the Agency to conduct diagnostic x-ray field survey tests. The course allows the Agency to maintain an adequate number of qualified FDA and state x-ray inspectors in the field.
  • Drafted proposed amendments to the Federal Laser Performance Standards 21 CFR 1040.10 and 1040.100, which adopt by reference and with national exceptions, the IEC laser standards (60825-1 and 60601-2-22) as the new Federal standard. The amendments move to create a single global regulatory environment for laser product manufacturers by reducing the regulatory burden on industry and updating the Federal standard to reflect current laser technology and bioeffects research.

Mammography Quality

The National Mammography Quality Assurance Advisory Committee

The National Mammography Quality Assurance Advisory Committee (NMQAAC) is a committee established by the Mammography Quality Standards Assurance Act (MQSA) to advise CDRH on the implementation of the MQSA program. A Committee meeting was held on April 19, 2004. During that meeting the Committee suggested several ways to streamline the MQSA inspection process and lessen the regulatory burden on mammography facilities. It also reviewed the issues facing MQSA with respect to the use of data compression algorithms and the digitization of film-screen mammograms.

MQSA Reauthorization

On October 25, 2004, President Bush signed H.R. 4555, "The Mammography Quality Standards Reauthorization Act of 2004", to amend the Public Health Service Act to revise and extend provisions relating to mammography quality standards. Provisions relating to the certification of mammography facilities were added, which codify existing certification practices. In addition, adjustments were made to the membership and frequency of the NMQAAC. Representatives from related industries will now serve as committee members, and the advisory committee meeting will now be required to meet once a year rather than twice a year. The reauthorization expires on September 30, 2007.

Additional Mammography Review Process (AMR)

An AMR is a review of clinical images and other relevant information to assure that the facility is in compliance with MQSA. CDRH has had preliminary discussions about AMRs internally and with approved accreditation bodies. We examined a number of issues specific to AMRs and Patient and Physician Notifications (PPNs) including:

  • reasons for requesting AMRs;
  • procedures for performing AMRs (number of cases and number of reviewers);
  • criteria used to evaluate AMRs;
  • methods for evaluating the effectiveness of Corrective Action Plans and/or PPNs; and
  • role of medical outcomes and other evidence in the AMR/PPN process.

Digital Mammography

This new technology promises to enhance mammography by reducing the need for some women to have additional exposures while allowing interpreting physicians to quickly and easily manipulate the images. CDRH’s Office of Device Evaluation (ODE) has approved the following Full Field Digital Mammography (FFDM) systems for commercial use:

  • General Electric (GE) Senographe 2000D, January 2000
  • Fischer SenoScan, September 2001
  • Lorad Digital Breast Imager, March 2002
  • Lorad Holgic Selenia FFDM System, October 2002
  • Siemens Mammomat Novation DR Full Field Mammography (FFDM) System, August 2004.

Once approved, a facility must apply to become accredited by an FDA approved accreditation body. Currently, there are 778 FFDM units accredited at 566 facilities in the U.S. CDRH has approved the following Accreditation Bodies to accredit FFDM units:

American College of Radiology 

  • GE Senographe 2000D (approved 12/18/02; became effective 02/15/03)
  • Fischer SenoScan (approved 07/24/03; became effective 08/15/03)
  • Lorad Selenia (approved 09/05/03; became effective 09/15/03)
  • GE Senographe DS Full Field Digital Mammography (FFDM) (approved 08/12/04; became effective 09/15/04)

State of Iowa

  • GE Senographe 2000D (approved 08/28/03; became effective 10/01/03)
  • Lorad Selenia (approved 08/28/03; became effective 10/01/03)

State of Texas 

  • GE Senographe DS Full Field Digital Mammography (FFDM) units within Texas (approved 08/12/04; became effective 09/15/04)
  • Fischer Imaging SenoScan, GE Senographe 2000D and
  • Lorad/Hologic Selenia Full Field Digital Mammography (FFDM) (approved and became effective on 05/21/04)

States as Certifiers (SAC)

The SAC program allows qualified states to assume certain key MQSA responsibilities. The program authorizes qualified states (currently Illinois and Iowa) to certify mammography facilities within their jurisdiction, to conduct annual inspections, and to enforce the MQSA quality standards under CDRH oversight. In May 2004, CDRH transitioned these SACs from the interim regulations to the final regulations.

Inspection Demonstration Program

Under the MQSA Reauthorization Act, Congress authorized FDA to undertake an inspection demonstration program (IDP) to assess the results of conducting some mammography inspections less frequently than annually. The purpose of the program is to evaluate whether selected mammography facilities can maintain the same level of quality without CDRH's current scrutiny through our annual inspections. In its final form, the IDP includes approximately 160 study group facilities and an equal number of controls in 14 States or other governmental jurisdictions that have agreed not to inspect these facilities under their own authority during the study period. The first half of these facilities were selected and notified in November 2001 and the second half were selected and notified in May 2002. Each facility was randomly selected from a set of eligible facilities on a jurisdiction-by-jurisdiction basis. The facilities must have had a clean inspection history for the last two inspections to be eligible. The facilities in the study group underwent biennial inspections during the demonstration program, during which inspectors looked at the same areas as the current annual inspections, except that they reviewed for the entire period since the last inspection date. All study group facilities were inspected by the end of August 2004. A report on the program, “The Effect of Reducing Inspection Frequency,” was published on the MQSA website, Mammography Matters, on January 12, 2005. The report is available at http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/default.htm.

MQSA Compliance Activities

CDRH conducted inspections of mammography facilities and found that more than 97% of the facilities met the MQSA inspection standards, with only 2% of the facilities showing Level 1 (most serious) problems.

In addition we:

  • 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 CDRH regarding the scorecard and other MQSA issues.
  • Implemented a new enforcement strategy that addresses how facilities should respond to serious (Level 1) inspection observations, and what follow-up actions CDRH may take if facilities do not correct the problems.
  • Issued a talk paper to notify patients and their referring physicians regarding a serious risk to human health as a result of mammograms performed at a mammography facility in Florida. The facility had refused to directly notify patients.
  • Formed the Repeat Observations Working Group as a recommendation from the Device Field Committee to explore new approaches to deal with facilities with repeated inspection observations over several inspections.

Research and Technology

CDRH X-ray Calibration Laboratory

Through the operation of the CDRH X-ray Calibration Laboratory, CDRH provides the necessary traceability to national standards for instruments used by FDA and state inspectors to measure x-ray exposures from CDRH-regulated products. The calibration laboratory is accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) and complies with ISO Standard 17025.

CDRH OSEL’s staff performed a total of 1393 accredited calibrations of radiation probes by irradiation in reference x-ray fields. CDRH also performed 688 electrical calibrations of radiation monitors and 142 calibrations of non-invasive kVp meters. Of the radiation probe calibrations, 67% were for FDA-owned instruments, 31% for State-owned instruments, and 2% for other federal agencies. The work output was distributed by program as follows: approximately 68% of the calibrated instruments were designated for the Radiation Control for Health and Safety Act (RCHSA) program, 25% for The Mammography Quality Standards Act (MQSA) program, 3% for other federal agencies, and 3% for internal laboratory use. In addition, staff performed an unspecified number of tests of Geiger-Mueller survey instruments and light meter calibrations.

CDRH Ionizing Radiation Measurements Laboratory (IRML)

In FY 04, CDRH’s Ionizing Radiation Measurements Laboratory (IRML) in OSEL invested over $200,000 on equipment and supplies for the RCHSA and MQSA field programs and to keep the calibration laboratory updated and traceable. The IRML staff researched instrumentation and equipment for x-ray testing; performed laboratory evaluations; prepared specifications and purchase requisitions; performed acceptance testing; distributed instruments based on inspection load, contracts, or agreements; maintained a database of instrument usage, repair, and calibration histories; repaired or arranged for repairs for all field instruments as needed; responded to inquiries regarding ionizing radiation measurements and instruments performance; and worked with OCER personnel on new test procedures. In addition, the laboratory staff made significant updates to the calibration laboratory’s automation systems, including fabrication of new electro-mechanical controllers and the near completion of new Labview software to control the calibration process.

IRML continues to contribute to the Center’s effort regarding the safety of x-ray security screening systems and actively participates in discussions with other agencies, users, and manufacturers on the need for new radiation safety standards. CDRH was instrumental in the April 2004 formation of Task Group N43.16. The group will develop a new ANSI standard on cargo screening systems. Currently, CDRH is facilitating the exchange of information by the different security agencies through the Interagency Steering Committee on Radiation Standards.

 Wireless Technology EMC for Medical Devices

FY 04 Program Accomplishments 

  • Performed electromagnetic compatibility (EMC) testing on wireless medical telemetry at three local hospitals to see how mobile radio transmitters might affect patient the older mobile radio frequencies information. The American Society for Healthcare Engineering (ASHE) located the hospitals, and ASHE and staff from the FCC engineering laboratory participated. This work is helping to convince hospitals to migrate to the protected WMTS frequencies
  • Developed computer modeling techniques for evaluating EMC between realistically-shaped medical implants and antennas. Validated these with laboratory experiments. Presented findings at a technical conference and published them in conference proceedings.
  • Developed unique, anatomically correct computer simulation models for pregnant women and children for human exposure studies with walk through (WTMD) and hand-held (HHMD) metal detectors. Formed collaboration with Dr. Ji Chen, University of Houston working under a National Science Foundation grant to develop an equivalent source model for human exposure to these security systems. Gathered data from emissions measurements on 3 WTMDs Submitted abstracts for presentations at the BEMS conference.
  • Performed testing and computer simulations with Bluetooth and IEEE 802.11 wireless technology that revealed significant coexistence and data latency (e.g., transmission slowdown and drop-outs) concerns. Observed that the widely used 802.11b technology can be adversely affected by Bluetooth and other in-band signals. Computer simulations confirmed these concerns, but issues about the interpretation of the computer simulations limit the use of the present tool.
  • Completed IAG project with the U.S. Army Telemedicine and Advanced Technology Research Center (TATRC) to study EMC and wireless technology among medical devices and wirelessly enabled PDAs.
  • Developed simulation tool for Bluetooth and IEEE 802.11b wireless technology to study data loss and corruption, latency, through-put, and coexistence with other wireless signals. A project report was presented to TATRC.
  • Performed the first international comparison of cell phone SAR computations and measurements with SAM (standard anthropomorphic man) phantoms under CRADA with the Mobile Manufacturers Forum (MMF). Over 15,000 data points from 14 national and international universities, test laboratories, and manufacturers were analyzed. Findings suggest that the SAM phantom produces higher SAR values than anatomically accurate computer models. This work is the first study to reveal the variations in SAR computations across several independent institutions for the same SAM phantom.
  • Completed magnetic field emissions measurements on 30 HHMDs creating unique, independent data about these security systems. Tested implanted cardiac pacemakers, implanted cardiac defibrillators, implanted neurostimulators, partially implanted drug infusion device for EMC with these security systems. Discovered one HHMD emits significantly higher fields (more than 600 A/m compared to typically up to 30 A/m from other HHMDs) that can affect pacemaker and neurostimulator output and a personnel drug infusion device. Reported preliminary findings to FAA/TSA under the IAG.

 Standards Development

FY 04 Program Accomplishments 

  • Established a new standards management database for the Intranet to facilitate Center-wide knowledge of our standards activities and our liaison representatives.
  • Established liaison representative training module that will be required annually.
  • Noted the largest recognition of standards since FDAMA.
  • Implemented the new guidance initiative and OSEL details to ODE to facilitate the development of guidances.
  • Established the Implantable Middle Ear Hearing Devices standard activity – from conceptual meetings to a draft ASTM standard.

 Workshop on Drug-Diagnostics Translational Research

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. On July 29, 2004 CDRH initiated a national workshop on the co-development of drugs and diagnostics. The purpose of this workshop was to allow for stakeholders to provide in a public venue scientific suggestions and concerns about CDRH regulatory practices in this important and growing new area. Over 300 members of CDRH, drug companies and diagnostic companies attended. The proceedings of this conference are being used by CDRH 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.

 Collaboration with Centers for Disease Control and Prevention

On June 28, 2004 CDRH published a letter to manufacturers of antimicrobial susceptibility tests pointing out a serious problem had emerged. It had been observed that because of mutation in an important disease causing bacteria (Staphylococcus aureus), automated test systems could not detect if they were sensitive or resistant to standard treatment using the antibiotic Vancomycin. This test failure had the potential to cause errors in treatment with serious consequences. Working with Centers for Disease Control and Prevention, CDRH developed recommendations for manual alternative tests to fill the gap, developed a procedure for companies to test modified systems to see if automated test systems could be adjusted to resolve this problem, and issued wide public health notice of this problem.

 Transmissible Spongiform Encephalopathy (TSE): Evaluation of Prion Decontamination Procedures

Creutzfeldt-Jakob disease (CJD,) a human form of transmissible spongiform encephalopathy (TSE) that occurs worldwide, is a rapidly progressive, invariably fatal neurodegenerative disorder believed to be caused by a prion protein. The World Health Organization has developed infection control guidelines for CJD that include the destruction of heat-resistant surgical instruments that come in contact with high-infectivity tissues. Since this safest and most unambiguous method may not be practical or cost effective, CDRH scientists examined the effects of using aggressive decontamination techniques on the instruments instead. The study results, including aggressive decontamination techniques that can be used as alternatives to the destruction of heat-resistant surgical instruments that come in contact with high-infectivity tissues, were published in the peer-reviewed scientific literature. A full report on this study is available on the Centers for Disease Control and Prevention (CDC) website. (See www.cdc.gov/ncidod/diseases/cjd/cjd_inf_ctrl_qa.htm). CDRH’s data are the basis of the CDC website’s cautionary warnings on TSE.

Guidance Development

CDRH worked with the Office of General Counsel and the Office of Policy Regulation editorial staff to review and revise all boilerplate templates for all guidance documents. These templates are available to the Center Good Guidance Practices (GGP) office representatives on the Center’s website.

The Center published a great number of final and draft guidance documents. The next two sections contain comprehensive lists of final guidance documents adopted and draft guidance documents published in FY 04.

 Final Guidance Documents Adopted

  • Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Sirolimus Test Systems
  • Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications
  • Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan
  • Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Noble Metal Alloys
  • Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Base Metal Alloys
  • FY 05 MDUFMA Small Business Qualification Worksheet and Certification - Guidance for Industry and FDA
  • Guidance for Industry: FDA Export Certificates
  • A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff
  • Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
  • User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff
  • FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff
  • Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff
  • Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff
  • Immunomagnetic Circulating Cancer Cell Selection and Enumeration System - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff
  • Spinal System 510(k)s - Guidance for Industry and FDA Staff
  • Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove - Guidance for Industry and FDA Staff
  • Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems - Guidance for Industry and FDA Staff
  • Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA
  • Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff
  • Cyanoacrylate Tissue Adhesive for the Topical Approximation of Skin - Premarket Approval Applications (PMAs) - Guidance for Industry and FDA Staff
  • Consumer-Directed Broadcast Advertising of Restricted Devices
  • Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation - Guidance for Industry and FDA Staff
  • Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff
  • Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA Staff
  • Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices - Guidance for Industry and FDA Staff
  • Expedited Review of Premarket Submissions for Devices - Guidance for Industry and FDA Staff
  • Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff
  • User Fees and Refunds for Premarket Approval Applications - Guidance for Industry and FDA Staff
  • Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff
  • Class II Special Controls Guidance Document: Endotoxin Assay
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus
  • Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm
  • The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System # 8
  • FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff

Draft Guidance Documents for Comment Purposes Only

  • Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
  • Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment
  • Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Bone Grafting Material
  • Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002 - Draft Guidance for Industry, FDA Staff, and FDA-Accredited Third-Party