U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. List of Highest Priority Devices for Human Factors Review
  1. Regulatory Information

GUIDANCE DOCUMENT

List of Highest Priority Devices for Human Factors Review Guidance for Industry and Food and Drug Administration Staff February 2016

Draft

Not for implementation. Contains non-binding recommendations.

List of Highest Priority Devices for Human Factors Review

Docket Number:
FDA-2015-D-4599
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA is issuing this guidance document in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions (i.e., for PMA, 510(k)). FDA believes these device types have clear potential for serious harm resulting from use error, and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices.

FDA's guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances 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 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:

Division of Dockets Management (HFA- 305)
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-2015-D-4599.