IVD Advisory Panels
This section describes how FDA works with the various panels
of the Medical Devices Advisory Committee to get input about In Vitro
Diagnostic Devices (IVDs). For more information, see Overview
of IVD Regulation, IVD Guidance
Documents, and IVD Standards.
What is the Medical Devices Advisory Committee?
The Medical Devices Advisory Committee is a group of outside experts that gives independent professional and technical advice to FDA. The Medical Devices Advisory Committee consists of 18 panels, each addressing a different medical device specialty. Each panel reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. FDA considers these recommendations when it makes its final decisions.
See also: Charter Amendment: Medical Devices Advisory Committee
Which panels cover IVD specialty areas?
Five panels cover IVD specialty areas. Follow the links below to determine the executive secretary, panel members, and five-digit code for each panel.
Who participates in IVD advisory panels?
Each IVD advisory panel consists of up to seven standing voting members and two nonvoting members (a consumer representative and an industry representative). Each voting member is an expert in a particular field with considerable clinical or scientific training and experience. Participants in advisory panels are not regular FDA employees, but are "special government employees". They are paid for the time they take from their daily occupations to provide their professional service to FDA.
How often do IVD advisory panels meet?
Each panel typically meets 1-3 times per year. The meetings are usually open to the public and there is time provided for public comment on the topics under consideration. Persons who wish to present their views must contact the executive secretary of the specific advisory panel and request time in advance.
Where can I find information about upcoming or past meetings?
When you call the FDA Advisory Committee Information Line, you will be able to hear general information about FDA advisory committees, and specific information about the committees and panels associated with any of the centers with advisory committees in FDA. For information on the panels associated with the Center for Devices and Radiological Health (CDRH), you can press "2" immediately. For information on a particular committee or panel, you can immediately press the five digit code for that committee or panel and bypass the general information.
See also: CDRH Advisory Committees
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