The FDA’s Pre-Submission (Pre-Sub) program allows sponsors to request feedback from the agency on their planned medical device submissions. The original Pre-Sub guidance (issued in 2014 and updated in 2017) described 6 specific mechanisms for feedback:
- Pre-Submissions
- Informational Meetings
- Study Risk Determinations
- Formal Early Collaboration Meetings (i.e., Agreement and Determination Meetings) Submission Issue Meetings
- PMA Day 100 Meetings
These were collectively referred to in the guidance as “Q-Submissions” (Q-Subs); therefore, Pre-Subs are a subset of Q-Subs. Confusingly, the agency uses both terms in a somewhat interchangeable fashion in other guidance, on the FDA web site, and in training materials. However, they are only interchangeable when referring to a Pre-Sub.
Under Medical Device User Fee Amendments of 2017 (MDUFA IV), industry and the FDA agreed to refine the Q-Sub Program. Refinements include changes to the scheduling of Pre-Sub meetings and a new performance goal on the timing of FDA feedback for Pre-Subs. An updated final guidance (replacing the older guidance) was issued on May 7, 2019. This new document clarifies the submission types that are covered by this guidance in detail (described in sections III.A-D), which types are submitted using the Q-Sub process but are covered by separate guidance documents (described in Section III.E-F), and types that are outside the scope of the Q-Sub program (described in Section III.G). The guidance also contains a clear outline of the Q-Sub process. The document closes with a statement that Q-Sub types created in the future will be described through appropriate mechanisms, indicating there is already discussion about expanding the program. Comments may be sent through the guidance web page. The new guidance is an excellent update to clarify a very important device program. Use it to constructively change your strategy map for clearance or approval of your new device or device-led combination product.
Text Copyright © 2019 Katrina Rogers
March 2022 postscript – The draft guidance discussed in this post became final in January, 2021.
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