Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Published

December 9, 2022

Last updated

December 8, 2022

Description

This document is a draft guidance for the FDA staff and industry on the content of human factors information in medical device marketing submissions.

Organization

Country / Region

United States

License

Other (Public Domain)

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