NAMSA White Paper: FDA Pre-Submission or Q-Sub Program

In Clinical, FDA by Erika Huffman

The US FDA’s Pre-Submission (Pre-Sub) program, which was established in 1995, provides medical device Sponsors the opportunity to obtain valuable FDA feedback prior to an intended submission of an IDE or marketing application. Since 1995 the program has grown to include several types of feedback meetings for potential or planned submissions, which are collectively now called Q-Subs.

The FDA encourages medical device Sponsors to take part in the Q-Sub program, which has become the most commonly used mechanism for obtaining FDA feedback prior to device submission. Feedback from FDA can be in the form of written responses to questions, a live teleconference, or face-to-face meeting. The most recent guidance on Q-Subs was released by FDA in February 2014.

“FDA Pre-Submission or Q-Sub Program,” a white paper by Erika Huffman, MSBME, RAC, Principal Medical Research Manager at NAMSA, details several types of informational/feedback meetings available under FDA’s Q-Sub program. Aside from the standard Pre-Submission meeting, the FDA program also includes a wide array of meetings for specific situations: Informational meetings (for Sponsors to inform FDA about upcoming submissions, particularly for multiple submissions or for a novel product), Study Risk Determination meetings (for pre-trial risk determination/confirmation from FDA), Agreement meetings (to reach agreement on an optimal investigational plan), Determination meetings (to discuss clinical trial design), Submission Issue meetings (to discuss potential issues identified during premarket review), and PMA Day 100 meetings (to discuss the status of a submitted PMA application that is under FDA review).

How Can NAMSA Help?

The Q-Sub program has become an essential part of medical device development and strategic planning not only because it can save missteps and surprises down the line, but also because it provides a rare opportunity to learn how FDA is thinking specifically about your product. The regulatory professionals at NAMSA have the experience to understand what types of Q-Subs are best for your product at which development stage and how to ask questions that get the answers you need from FDA.

Next Steps

Authors:

Erika Huffman, Medical Research Manager - Regulatory, joined NAMSA in 2010. She holds an MS in Biomedical Engineering from the University of Iowa and has over 18 years of experience in the medical device industry, having worked in Regulatory, Quality and Management roles with both US and international focus. Her experience includes premarket submissions and post-marketing surveillance for Class II and III devices, including software/firmware and active implantables. Ms. Huffman holds a current Regulatory Affairs Certification (RAC).