On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA prior to the submission of a premarket application (PMA, 510(k), HDE, IDE, de novo, etc.). The sponsor may submit a pre-submission application to the FDA requesting answers to various questions about the marketing application or clinical trial design of their device. The sponsor may request a written response, teleconference, or meeting. The FDA has committed respond to the sponsor within 75 to 90 days.

Many of our clients are making use of the pre-submission process to gain clarity on the expectations of the FDA. This process is especially useful for technologies that are novel, do not have device specific guidance documents or standards, or have an unclear regulatory pathway. The best time to submit a pre-submission request is during the development of the proposed technology and prior to commencing any bench, animal or clinical studies that could cost significant time and money. In Appendix 1 of the guidance document for pre-submissions, you can find common questions that can be asked during a pre-submission process.

This final publication of the guidance for the Pre-Submission Program is overall very similar to the Pre-Submission draft guidance. There are a number of minor changes and updates for clarity. The main change is that other types of meetings (Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings, Submission Issue Meetings, and PMA Day 100 Meetings) will now fall under the same organizational structure as the pre-submissions. All meeting types will be given a “Q” number (i.e. Q140001), and will be referred to as a Q-Sub. Separate guidance documents exist for the ‘other’ types of meetings referenced in the Pre-Submission guidance document.

The process so far has proven beneficial for our clients. As we continue to work collaboratively with the FDA, we anticipate greater clarity of FDA’s expectations and less surprises during the premarket review process.

Have you used the pre-sub process? What was your experience?

- Sherri

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