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GUIDANCE DOCUMENT

Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff August 2026

Download the Final Guidance Document
Final
Docket Number:
FDA-2011-D-0469
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides the FDA’s recommendations to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments. The recommendations in this guidance document are intended to support manufacturers in improving the design of devices to minimize potential use errors and resulting harm. The FDA believes that these recommendations will enable manufacturers to assess and reduce risks associated with medical device use.

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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-2011-D-0469.

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