List of Highest Priority Devices for Human Factors Review: Draft Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Investigational Device Exemption (IDE), Labeling, Postmarket, Premarket, Safety - Issues, Errors, And Problems

Published

February 3, 2016

Last updated

May 14, 2019

Description

This document is a draft guidance for industry and FDA staff, listing highest priority devices for human factors review.

Organization

Country / Region

United States

License

Other (Public Domain)

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