FDA Guidance on AI Requests

FDA releases Guidance on AI requests.  To aid manufacturers and reviewers, this guidance emphasizes the “Least Burdensome Provisions” when responding to deficiencies in a regulatory submission.  Download the final guidance: 2022-guidance-responding-deficencies-least-burdensome

As stated by FDA, this guidance is “intended to help FDA staff develop, and industry respond to, a request for additional information needed to make a decision on a medical device marketing application in accordance with the Least Burdensome provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Updates to the 2017 version of this guidance were made “to clarify what constitutes a statement of the basis for the deficiency” consistent with commitments as outlined in the Medical Device User Fee Amendments of Fiscal Years 2023 Through Fiscal Year 2027 Commitment Letter.”

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

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  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
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