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.”
