Posted 06 February 2013
By Alexander Gaffney, RF News Editor
The US Food and Drug Administration (FDA) is calling for the nomination of new voting members to serve on several of its medical device-related public advisory committees, saying it will accept nominations for all current vacancies as well as those to occur before the end of 2013.
The committees include the Device Good Manufacturing Practice Advisory Committee, as well as device-related panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee and the Technical Electronic products Radiation Safety Standards Committee of FDA's Center for Devices and Radiological Health (CDRH).
The panels and committees are commonly used by FDA to evaluate novel or high-risk products to determine if the experts believe them to be safe and effective for their indicated use. Though influential, FDA is not obligated to take the committees' advice, and takes positions contrary to theirs several times each year, usually in cases where the committee in question was closely divided.
The committees are also used to review guidance documents, classify devices according to their perceived risk, recommend broad-scale actions like banning certain devices, and reviewing specific postmarketing safety issues.
Nominations to open positions-there are 49 open spots in all-must include a resume or current curriculum vitae, address, and detailed information regarding potential conflicts of interest. Nominees may be self-nominated or nominated by others. In the latter case, the nominating party must attest that the nominee is aware of the nomination.
The open committee positions are as follows:
- National Mammography Quality Assurance Advisory Committee - (1)
- Technical Electronic Product Radiation Safety Standards Committee - (2)
- Device Good Manufacturing Practice Advisory Committee - (2)
- Medical Devices Advisory Committee - (44)
- Anesthesiology and Respiratory Therapy Devices Panel - (3)
- Circulatory System Devices Panel - (1)
- Dental Products Panel - (3)
- Hematology and Pathology Devices Panel - (4)
- Orthopaedic and Rehabilitation Devices Panel - (3)
- Gastroenterology and Urology Devices Panel - (5)
- Microbiology Devices Panel - (4)
- Obstetrics and Gynecology Devices Panel - (2)
- Radiological Devices Panel - (2)
- General Hospital and Personal Use Devices Panel - (4)
- Immunology Devices Panel - (2)
- Ophthalmic Devices Panel - (2)
- Neurological Devices Panel- (1)
- Medical Devices Dispute Resolution Panel - (1)
- Ear, Nose and Throat Devices Panel - (3)
- General and Plastic Surgery Devices Panel - (2)
- Molecular and Clinical Genetics Devices Panel - (2)