Discover the Power of Communication: Why Talking to FDA Isn't Scary, But Incredibly Useful!

Regulatory bodies such as the US Food and Drug Administration can feel intimidating, almost like the governing body hiding in an ivory white tower. But there is an official program that gives Sponsors at any stage in device development to ask FDA questions and receive feedback to ensure the most successful regulatory strategy.

The program, called the Q-Submission Program, is an opportunity to request feedback from FDA about various topics including clinical studies, performance testing, and even regulatory strategy. Even when Sponsors know about this program, they often steer away thinking that communicating with FDA early in device development will only hinder their innovation. But in reality, the use of the Q-Submission program can help the Sponsor are various parts in the total product lifecycle or even during premarket submission.

The program itself was started in 1995 as a mechanism for Sponsor's to obtain feedback prior to submitting a investigational device exemption but overtime the program has evolved to include nine types of submissions. This post will focus on Pre-Submissions, the submission that is intended to support Sponsor communication with FDA prior to premarket submission.

Pre-Submissions are an opportunity for Sponsors to request feedback to 3-4 questions from FDA at any point throughout device development but prior to premarket submissions. The questions can be as high level as "we would like feedback and guidance on pursuing a De Novo request" to as detailed as "does FDA agree that we use the sterilization specifically outlined in the FDA recognized consensus standard?" And the fun part? You can even request an in-person meeting and meet your potentially future review team in Silver Springs! You can submit numerous Pre-Submissions throughout your device development, but just remember that it takes about 70-75 days from submission until you have your meeting. Along with all of these fun things is that Pre-Submissions are free to submit!

The submission itself includes recommended information as outlined in the FDA Guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, including a device description, proposed indications for use, proposed regulatory path, the questions the Sponsor wants to ask, and three proposed meeting dates to meet with FDA. About two months after submitting the Pre-Submission, the Sponsor will receive written feedback and this is when you being to prepare for the meeting. The meeting is the space to meet your future review team, ask for any clarification from the Agency's written feedback, and to really dig into how to incorporate FDA's feedback into your regulatory strategy.

Although often overlooked or brushed off, Pre-Submissions are an excellent avenue to obtain FDA's feedback on specific topics from FDA as you refine your regulatory strategy. The success of a regulatory strategy can really make or break a business strategy, so take advantage of the programs FDA has to help make you get market authorization quickly!

If you have any questions, would like to discuss Pre-Submissions, or would like to submit a Pre-Submission don’t hesitate to reach out. You can reach Michelle at michelle@aetheriumregulatoryconsulting.com.

Michelle Rubin-Onur, PhD is the Founder and Principal consultant at Aetherium Regulatory Consulting. With over 10 years of experience in biomedical sciences and regulatory affairs, she has helped MedTech companies at all stages successfully navigate the FDA review process and build relationships with FDA reviewers.