The FDA has updated its pre-submission meeting program via a new draft guidance document that provides a framework for FDA’s increasingly popular program that provides medical device companies with the opportunity to receive input from the Agency prior to beginning a costly test program or premarket submission. The “Draft Guidance for Industry and FDA Staff Medical Devices: Pre-Submission Program and Meetings with FDA Staff” is designed to help manufacturers considering an IDE, 510(k), HDE, or PMA submission decide whether it would be beneficial to schedule a re-submission meeting.
Of particular importance to medical device companies is to understand that the pre-submission meeting is not intended to be a primer on FDA policies, but to be used for data preview or for asking questions about a review that is currently in progress. The new guidance document explains that these meetings are for asking specific questions about a particular submission, such as when dealing with new technologies or making decisions prior to the execution of a study related to the product.
The feedback that is provided by the FDA via this expanded version of the pre-submission program is intended to help medical device manufacturers prepare better submissions, a particularly sore point with the Agency that has been referred to time and again when discussing delays in the clearance/approval process. In addition to providing guidance regarding submissions, the program provides a mechanism for the Agency to provide advice to applicants who are developing protocols for clinical studies for which an IDE would not be required, such as studies of non-significant risk (NSR) devices or for clinical studies conducted outside of the U.S. to support future U.S. marketing applications.
As part of its continued pledge to provide greater transparency and more predictable interactions between industry and regulatory officials, the guidance document identifies specific items that should be included in a pre-submission package. While some elements are fairly self-evident, such as the need for a cover letter and a table of contents, other required items delineated by the FDA include a request for the preferred means of feedback to be transmitted to the submitting company, summaries of product discussions and the development process up to the point in time that the request was made. The guidance also explains different types of meetings that can occur between medical device manufacturers and regulatory officials throughout the submission and pre-submission process.
Aptiv Solutions has extensive experience navigating the FDA pre-submission process. We can help clients decide if a pre-submission meeting is appropriate for their device and if so, support the client with determining the correct timing for the meeting and developing the questions to be discussed.
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Aptiv Solutions Blogging Team