Content of Human Factors Information in Medical Device Marketing Submissions

9 December 2022 – the FDA published the draft guidance on medical device marketing submissions for industry and FDA staff. Submit comments by 9 March 2023.

This guidance includes FDA’s recommendations for the content of human factors and usability information to be included in marketing submissions. The marketing submission should, where appropriate, demonstrate that the needs of the intended users were considered in the device design and that the device is safe and effective.

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