Engage with the FDA During Your Premarket Submission Review to Enhance Your Success

A couple of weeks ago we discussed Pre-submissions and how they are a useful mechanism to speak to FDA during device design and development, but did you know you can actually also speak to FDA during your premarket review?

A Submission Issue Request (SIR), also a Q-submission type, is a mechanism to speak to FDA once you have received a hold letter with questions from the Agency during a submission review. Specifically, a SIR allows for Sponsors to request FDA feedback on a proposed approach or strategy to address any issues conveyed by FDA in an Additional Information hold letter, a Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications hold letter, an Investigational Device Exemption Letter or an Investigational New Drug Clinical Hold Letter. Similar to a Pre-Submission, it does not have a MDUFA user fee associated with it!

The exact content and timeline for a SIR is outlined in the FDA Guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Timeline wise, you can submit a SIR within 60 calendar days or after 60 calendars days. If submitted within 60 days, FDA will aim to provide feedback within 21 days. But if submitted more than 60 days, FDA will aim to provide feedback within 70 days. So I always recommend that Sponsor's submit a SIR within 60 days.

SIR are not required or necessary but it can be a very helpful in specific situations and can help you get a favorable FDA decision. For example, if your review team asks for additional human factors data, you can submit a SIR with your proposed human factors study protocol to ensure that the protocol and your approach addresses the issues that are outlined in the hold letter. The questions included in your SIR should be clear and specific to ensure that the conversation is productive and results in informative feedback from the Agency.

Similar to a Pre-Submission, you can request written feedback or a teleconference meeting to discuss FDA's response. Interestingly, unliked in a Pre-Submission, you cannot request both. So if you request a meeting, written feedback will not be provided. The meeting minutes from the meeting will act as the record of the feedback and the discussion. This record is the meeting minutes that are submitted by the Sponsor within 15 calendar days of the meeting.

It's important to remember that a SIR is not the place to obtain FDA's feedback on any additional or data or information, that is done through your response letter. The formal response to FDA's letter should still be submitted within the timeline outlined in the letter (e.g., 180 days maximum for an Additional Information Hold Letter) regardless whether a SIR is submitted or not.

Although it may sound like submitting a SIR could add to your response timeline, it can be extremely useful submission if you want to ensure that your planned approach or strategy aligns with FDA's thinking. After all, spending a little bit more time ensuring that your response will address FDA's issues is worth the time rather than a negative decision. Just like FDA is going to consider the benefit-risk of your device, you should also consider the benefit-risk of any approach you take.