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FDA Tweaks Q-Sub Meeting Guidance

 
• By Elizabeth Orr

The revised guidance document clarifies the Q-submission meeting process, alternate ways sponsors may obtain FDA feedback, and more.

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• Source: Shutterstock

A full revision of the US Food and Drug Administration’s Q-submission (Q-Sub) guidance document, which details how manufacturers may request meetings with the agency, is coming. But while that is in the works, the agency has issued a new version of the 2019 final guidance that attempts to clarify a range of issues.

The FDA promised as part of last year’s Medical Device User Fee Amendments (MDUFA V) package that it would issue a revised draft Q-Sub guidance that included information on when...

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