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Guidance Issuing OfficeCenter 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.
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:
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.