FDA Issues New Guidance on Q-Submission Meetings for Devicemakers

June 11, 2018

The FDA released new draft guidance on meetings devicemakers may request under the agency’s Pre-Submission Program — also known as Q-submission meetings because the agency assigns applications a Q number.

The draft replaces the FDA’s guidance on requests for feedback on medical device submissions finalized in 2017 to include changes made under MDUFA IV, as well as providing clarifications on the Q-sub program.

The draft guidance covers numerous categories of device-related submissions, ranging from IDEs, 510(k) submissions, de novo requests and premarket applications to humanitarian device exemptions, and also applies to pre-submission feedback and certain INDs.

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