FDA Issues Final Guidance for Content of Human Factors Information in Medical Device Submissions June 3, 2026 By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

https://www.thefdalawblog.com/2026/06/fda-issues-final-guidance-for-content-of-human-factors-information-in-medical-device-submissions/?utm_source=rss&utm_medium=rss&utm_campaign=fda-issues-final-guidance-for-content-of-human-factors-information-in-medical-device-submissions On May 29, 2026, FDA issued a final guidance, Content of Human Factors Information in Medical Device Marketing Submissions (Final Guidance), replacing the draft version issued in December 2022 (Draft Guidance). FDA has requested human factors (HF) information in some premarket submissions for years, but it has not always been clear, especially for 510(k)s, which device types would require HF testing as part of the submission.