FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction
FDA Law Blog
APRIL 30, 2024
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions. The draft guidance attempted to clarify when a Sponsor’s question may be more appropriate for more informal communication.
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