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GUIDANCE DOCUMENT

Procedures for Meetings of the Medical Devices Advisory Committee Guidance for Industry and Food and Drug Administration Staff September 2017

Final

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2015-D-0838
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The Center for Devices and Radiological Health (CDRH) is issuing this guidance to provide information regarding the processes for meetings of the Medical Devices Advisory Committee panels other than the Medical Devices Dispute Resolution Panel (DRP). The term “panel,” as used in this guidance, refers to the panels described in the Medical Devices Advisory Committee charter, excluding the DRP. This guidance describes the general circumstances in which CDRH consults with a panel; the process for exchange of information between CDRH, the members of the panel, industry, and the public; and the conduct of panel meetings.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-0838.