On 7 May 2019, FDA issued a document, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”. This guidance supersedes “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff,” dated 29 September 2017. As part of the Medical Device User Fee Amendments of 2017 (MDUFA IV), industry and the Agency agreed to refine the Q-Sub Program with changes related to the scheduling of Pre-Sub meetings and a new performance goal on the timing of FDA feedback for Pre-Subs.4 This guidance reflects those changes and clarifies other elements of the Q-Sub program.
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