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INFORMATION SHEET

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

Download the Final Information Sheet
Final
Docket Number:
FDA-2006-D-0031
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, 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). 

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Submit Comments Online

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-2006-D-0031.

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