- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical PracticeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
This guidance is intended to assist clinical investigators and institutional review boards (IRBs) by answering common questions FDA receives concerning medical devices. This document supersedes Medical Devices, Frequently Asked Questions about IRB Review of Medical Devices, and Emergency Use of Unapproved Medical Devices (September 1998) Office of Health Affairs, Food and Drug Administration. This document was revised to make it consistent with the Agency’s good guidance practices regulations (21 CFR 10.115).
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-2006-D-0031.