Q-Submissions – Hot Off the FDA Press

I’d like to welcome back part of the McCormick LifeScience Team, Diane C. Tiernan, M.S., RAC, a Device Regulatory professional possessing >25 years industry experience. Diane has worked in large and small device companies, and is currently a private medical device consultant.

Hit it Diane!

To my colleagues in the biotech industry, whether you are in the regulatory affairs field or not, you understand the terms “Type A meeting”, “Type B meeting”, “End of Phase Two meeting”. The idea behind defining these types of meetings is a by-product of PDUFA and is intended to streamline the review process of regulatory submissions by the Center for Drug Evaluation and Research (CDER) and the Center for Biological Evaluation and Research (CBER).

The Center for Devices and Radiological Health, or CDRH has also held meetings with sponsors, specifically pre-IDE meetings to discuss a sponsor’s plan for clinical trials for an emerging medical device technology. In fact, FDA has, like CDER and CBER, had a guidance in place (“Pre-IDE Program: Issues and Answers – Blue Book Memo D99-1”, dated March 25, 1999) outlining the steps necessary to request a meeting with CDRH as well as the elements of a pre-IDE package, the time needed to review the package and designating a meeting date and time with FDA.

business conference microphonesOver time, it became apparent to FDA that there were other types of requests by sponsors that logically necessitate a meeting in advance of submitting a regulatory document including a pre-IDE package. These documents are now referred to as “Q-Submissions“. On July 13, 2012, CDRH issued an update to the Pre-IDE Program Blue Book Memo, “Requests for Feedback on Medical Device Submissions:Â The Pre-Submission Program and Meetings with FDA Staff.” According to a February 26, 2014 Webinar presented by members of CDRH and CBER, “The Pre-Submission Program replaces and improves on the pre-IDE Program by expanding the program to include all types of feedback requests prior to any medical device submission.

The draft guidance was updated, finalized and issued within the past 6 weeks on February 18, 2014.

FDA conducted a very informative Webinar on February 26, 2014 to discuss the final guidance (“Requests for Feedback on Medical Device Submissions:Â The Pre-Submission Program and Meetings with FDA Staff“) and respond to questions associated with this Pre-Submission Program and the Q-Submissions.

Dr. SomaKalb, ActingDirector of theIDE Program in the Office of Device Evaluation (ODE) at CDRH, explained the final guidance as follows:

“The final guidance establishes a structured process for sponsors who submit pre-submission requests and for FDA staff and managers involved in their review. It also explains, in detail, the Q-Submission structure the FDA is using to track feedback mechanisms and outlines each interaction type, including what is and is not tracked as a Q-Submission.

The final guidance includes the refuse to accept checklist as an appendix to outline what FDA is looking for in the acceptance review. One of the updates to the guidance includes this helpful table that lists the different Q-Submission types. It also indicates whether a meeting is associated with those types and gives a timeframe for receiving feedback on the Q-Submission. As you can see, pre- submission is one type of Q-Submission but there are several others.

These include informational meeting, study risk determination, agreement meeting, determination meeting, submission issue meeting and PMA Day 100 meeting. It is important to note that there are some types of inquiries that are not considered Q-Submission.”

A video of the Webinar (Titled, “Online Video Presentation”) as well as a copy of the slides presented (below) and a transcript (below) of the presentation (including the Q&A) are located on FDA Medical Device website under “CDRH Learn” (link below).

Link to CDRH Learn
Link to Slide Presentation
Link to Transcript

There is a lot to digest in this final guidance; too much to cover in this newsletter. We encourage you to take a look at the video presentation of the webinar as well as the slides and transcript.

We would love to hear your feedback on how the Q-Submissions process is working for you! Please address comments to: Kelsey@mccormicklifescience.com

Best of luck, my medical device comrades!

Toto's Tips

  • At a minimum, be sure to familiarize yourself with this final guidance!!! CDRH and CBER have made it abundantly clear that they expect sponsors to follow this final guidance when planning a pre-submission meeting with them (FDA).
  • Do not hesitate to use pre-submission meetings as an opportunity to apprise FDA of your plan. Review the webinar, slides, and transcripts available online here.