You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit e lectronic comments to Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document, contact Ron Kaye at or (301) 796-6289, or Molly Story at or (310) 796-1456.

When final, this document will supersede Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management (Issued July 18, 2000).


U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of Device Evaluation


Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number 1757 to identify the guidance you are requesting.

Table of Contents

Draft Guidance for Industry and Food and Drug Administration Staff

Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

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1 21 CFR 820.30

2 See Draft Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions, released on April 23, 2010. When final, this will represent FDA’s guidance on this topic.

3 21 CFR §820.250

4 Clinical studies must comply with the Investigational Device Exemption requirements set out in 21 CFR §812.

5 e.g., Virzi, 1992; Nielsen, 1993