New Draft Guidance Issued by FDA on Content of
Human Factors Information in Medical Device Marketing Submissions




The U.S. Food and Drug Administration issued draft guidance Thursday, December 9, 2022 for comment purposes. The guidance includes non-binding recommendations intended to improve review of medical device submissions. The document titled: Content of Human Factors Information in Medical Device Marketing Submissions provides suggested human factors information to be included in medical device marketing submissions.


Shannon weighs in on the U.S. FDA Draft Guidance issued on December 9, 2022, on Content of Human Factors Information in Medical Device Marketing Submissions.



Stay tuned for our blog post detailing the guidance in a comprehensive breakdown and weighing in on some implications for medical device marketing submissions.

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Do you need assistance navigating FDA guidance on medical device marketing submissions or human factors for medical devices? UserWise is available to help and has expertise on multiple international human factors standards. 







︎ Shannon Clark | December 9, 2022


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