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Calling A Q-Sub: New Guidance On Seeking Feedback From FDA

 
• By David Filmore

A new US FDA draft guidance on the "Q-Submission Program" (Q-Sub) spotlights certain mechanisms, including pre-submissions, available to sponsors to interact with the agency before or after actually submitting a 510(k), PMA, IDE or other specific submission.

Can telephone with red wire

US FDA posted a draft guidance June 6 fleshing out procedures, timelines and tips for companies seeking agency feedback in advance of a pre-market submission or after the review process has begun.

The new document on the "Q-Submission Program" (Q-Sub) attempts to provide a lay of the land on certain mechanisms available to sponsors to interact with the agency at times other than when actually submitting a 510(k), PMA, IDE or other specific submission

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