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Frequently Asked Questions About Medical Devices Guidance For IRBs, Clinical Investigators, and Sponsors January 2006

Issued by:
Guidance Issuing Office
Office of Good Clinical Practice
Center for Devices and Radiological Health
Center 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). 

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.