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GUIDANCE DOCUMENT

Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff February 2016

Final

This guidance is being distributed for comment purposes only.

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

FDA has developed this guidance document 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.

FDA's guidance documents, including this one, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.


Submit Comments

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.