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GUIDANCE DOCUMENT

Content of Human Factors Information in Medical Device Marketing Submissions Draft Guidance for Industry and Food and Drug Administration Staff December 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2015-D-4599
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides the FDA’s recommendations on the human factors information that should be documented and included in medical device marketing submissions, when such are required. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions.

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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-2015-D-4599 .

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