FY 2005 ODE Annual Report - Part 6 - Other Program Activities
ODE continues to be involved in several critical initiatives related to national bioterrorism preparedness and response. ODE established liaisons and continues to collaborate with other government agencies and the military to prepare for and assume regulatory responsibilities applicable to medical devices that are critical to bioterrorism preparedness efforts. ODE is currently developing guidance and procedures for timely premarket review and approval of these devices.
Transmissible Spongiform Encephalopathy (TSE)
ODE continues to be actively involved in agency and CDRH TSE activities. ODE in coordination with other CDRH offices, CBER, CDER, and CFSAN has worked to develop regulations to add further safeguards in the selection of bovine materials used in medical products. Along with CDRH and these other centers, ODE has participated in the Center for Biologics February and October 2005 FDA CBER TSE Advisory Committee (TSEAC)
meetings. At the October meeting, ODE presented the results from the September 27, 2005 meeting of the General Hospital and Personal Use Devices Advisory Panel meeting that discussed acceptable criteria for studies and claims related to TSEs. The ODE presentation also provided an update indicating there were no medical devices that have been cleared or approved with claims to reduce or remove TSE infectivity on surgical instruments. ODE and other CDRH offices have continued to be active in the intra-agency working group dealing with Chronic Wasting Disease (CWD) Decontamination.
Advisory Panel Activities
The Center’s Medical Devices Advisory Committee (MDAC) consists of 18 panels, 13 in ODE and 5 in OIVD, that provide clinical and scientific advice to FDA in a wide range of medical specialties that are fundamental to the regulation of medical devices. The primary work of these panels involves: (1) review and recommendations on premarket submissions, primarily Premarket Approval Applications (PMAs), and 510(k)s, (2) classification and reclassification of medical devices based on risk to patients, (3) advice on guidance documents that provide industry and FDA staff with expectations for studies and data for premarket reviews, and (4) input on new issues or questions concerning the determination of the safety and effectiveness of medical devices.
In FY 05, 16 ODE panel meetings were held. These panels reviewed and made recommendations on 9 PMAs, 1 HDE, 2 510(k)’s, 7 preamendment device classifications, 1 OTC designation and 5 general issues. The ODE panels reviewed PMAs for significant device breakthrough technologies such as a thoracic endoprosthesis for endovascular repair of the descending thoracic aorta, a mesh wrap implant for restraining cardiac dilatation, a resurfacing hip system, a fetal monitor that uses ST waveform analysis, as well as silicone gel breast implants.
In FY 05, CDRH submitted approximately 53 homework assignments to Committee Management for clearance of Special Government Employees to provide outside expertise regarding various issues. Twenty Voting Members and 60 Consultants were cleared for these assignments. One waiver was required. The Center sought input from Advisory Panel members on the following types of documents: PMAs, PMA Supplements, PMA Amendments, 510(k)s, pre-IDEs, IDEs, HDEs, Postmarket Initiative (MDRs and PMAs), Guidance documents and general scientific discussions.
In FY 05, there were 15 training sessions for new ODE panel members and consultants. At 8 of the ODE meetings there were briefings on the new postmarket study design and follow-up procedures introduced on January 1, 2005, and at 7 ODE meetings there was a presentation about FDA’s Critical Path Initiative.
CDRH continuously recruits and selects highly qualified experts to serve as members and consultants on these panels. Potential candidates are asked to provide detailed information concerning financial holdings and employment as well as research grants and contracts to identify any potential or imputed conflicts of interest. Individuals interested in becoming panel members should send their curriculum vitae to Geretta.Wood@fda.hhs.gov.
The MDAC panels ensure that the agency has access to the nation’s outstanding medical and scientific experts and make the FDA medical device review process transparent to all stakeholders. CDRH greatly appreciates the many contributions that the advisory panel members and consultants make to the challenging tasks of the medical device review process.
The following 10 ODE panels of the Medical Devices Advisory Committee met during FY 05:
- Anesthesiology and Respiratory Therapy
- Circulatory System
- Dental Products*
- Ear, Nose and Throat*
- Gastroenterology and Urology
- General and Plastic Surgery
- General Hospital and Personal Use
- Obstetrics and Gynecology
- Orthopaedic and Rehabilitation
*Joint panel meeting
Transcripts from the Medical Devices Advisory Committee meetings can be found at:
ODE Application Integrity Program
Under the Application Integrity Program (AIP), ODE has considered many cases concerning the integrity of data submitted to the agency in premarket applications. During FY 05, we placed one application on Integrity Hold and removed the Integrity Hold on two applications.