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.

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