FDA Federal Register Announcement Requests Nominations for Voting Members on Public Advisory Panel

August 24, 2005

FDA Federal Register Announcement Requests Nominations for Voting Members on Public Advisory Panel

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Radiological Devices Panel of the Medical Devices Advisory Committee. There will be two openings for this panel starting on February 1, 2006.

The Radiological Devices Panel of the Medical Devices Advisory Committee performs the following duties:

  1. Advises the Commissioner of Food and Drugs (the Commissioner) regarding recommended classification or reclassification of devices into one of three regulatory categories.

  2. Advises on any possible risks to health associated with the use of devices.

  3. Advises on formulation of product development protocols.

  4. Reviews pre-market approval applications for medical devices.

  5. Reviews guidelines and guidance documents.

  6. Recommends exemption of certain devices from the application of portions of the act.

  7. Advises on the necessity to ban a device.

  8. Responds to requests from the agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. May also make appropriate recommendations to the Commissioner on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices.

NOMINATIONS: Any interested person may nominate one or more qualified persons for membership on one or more of the advisory panels or advisory committees. Self-nominations are also accepted. Nominations shall include complete curriculum vitae of each nominee, current business address and telephone number, and shall state that the nominee is aware of the nomination, is willing to serve as a member, and appears to have no conflict of interest that would preclude membership. FDA will ask the potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest.

DATES: Because scheduled vacancies occur on various dates throughout each year, no cutoff date is established for the receipt of nominations. However, when possible, nominations should be received at least 6 months before the date of scheduled vacancies for each year, as indicated in this notice.

ADDRESSES: Send all nominations and curricula vitae to the following contact person:

Nancy J. Pluhowski
Center for Devices and Radiological Health (HFZ-400)
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
or e-mail: NJP@CDRH.FDA.GOV