Day-100 PMA meetings offer a critical mid-review checkpoint for high-risk devices. Learn how to request, prepare, and leverage these sessions to address deficiencies early, align with FDA expectations, and keep your Premarket Approval application on track.
Premarket Approval (PMA) applications – required for high-risk Class III devices – undergo a rigorous FDA review process. A unique feature of the PMA review is the optional Day-100 Meeting, a one-time mid-review checkpoint (around 100 days into FDA’s evaluation) where the sponsor and FDA meet to discuss the application’s status. Using the Day-100 meeting strategically can be a game-changer: it’s an opportunity to hear early feedback on deficiencies, address FDA’s concerns, and ensure your PMA stays on a viable path to approval. In this section, we explain the purpose and timing of Day-100 meetings and how to prepare for and leverage them effectively.
By regulation (21 CFR 814.40), FDA aims to complete PMA reviews within 180 days. Partway through this process, sponsors may request a meeting to get an update. An FDA guidance describes the Day-100 Meeting as a forum to “discuss the review status of their PMA”. In practice, the FDA will inform the applicant of any identified deficiencies or questions about the application prior to or during this meeting. Topics often covered include issues FDA has found in the data (safety or efficacy concerns), the status of any advisory panel referral (whether the PMA will need panel review), and planning for remaining review steps.
The meeting is called “Day-100” because FDA’s goal is to hold it no later than 100 days after filing the PMA (assuming the applicant requests it). Importantly, you must request the Day-100 Meeting in advance – FDA recommends doing so in the original PMA cover letter or via a Q-Submission within 70 days of PMA filing. This lead time allows FDA to schedule and prepare for the meeting by Day 100. If you don’t request it, FDA will assume you don’t need one (and in some cases with very straightforward PMAs, sponsors choose not to have a Day-100 meeting). However, many experts advise always requesting it up front – you can later cancel if it turns out to be unnecessary. It’s generally better to have it on the calendar and then decide you don’t need it, than to realize at Day 80 that you want a meeting and be too late.
The Day-100 meeting is essentially a mid-cycle check-in. It serves several key purposes:
In short, the Day-100 meeting de-risks the remainder of the review. As one regulatory law firm summarized, the updated FDA guidance “now includes a dedicated section on PMA Day 100 meetings” and reinforces that FDA “aims to hold a PMA Day 100 Meeting no later than 100 days after receipt of a PMA … [and] it can be requested in the cover letter or by separate Q-Sub.” This underscores FDA’s commitment to this process as part of MDUFA performance goals to keep sponsors informed mid-review.
Even though you request the meeting, the burden of preparation is lighter on the sponsor’s side compared to a Pre-Sub or panel meeting. FDA will be doing most of the talking at Day-100. However, you should still prepare carefully:
The FDA will typically walk through their list of deficiencies or discussion points. Listen carefully and take detailed notes (you will need them for follow-up). Do not hesitate to ask for clarification: “Could you elaborate on what you mean by ‘inconsistency in device manufacturing data’? Which part of the submission is this referring to?” It’s critical you fully understand each issue. Often FDA may send a written Day-100 memo or list of deficiencies just before the meeting – if so, use the meeting to clarify exactly what is needed for each.
For deficiencies that you can address with additional information, confirm the format and content FDA expects. For example, if a bench test needs to be redone, ask if a protocol review is needed, or what endpoints would satisfy the concern. This ensures that when you submit your responses (likely in a PMA amendment), they hit the mark.
If FDA raises the possibility of a panel, discuss timing and preparation. FDA might not have decided yet, but if certain questions remain open, a panel could be on the table. You can use this heads-up to begin identifying panel experts or gathering additional data prior to a meeting.
Then, execute on the action items. If data or analyses must be submitted, gather them as quickly as possible in a well-documented PMA amendment. If an advisory panel is planned, shift into panel preparation mode (refer to the earlier section on advisory committees). If no panel, focus on answering all FDA’s concerns so that by the time FDA’s final review wraps up, there are no loose ends.
The Day-100 meeting is a powerful touchpoint in the PMA process. Instead of waiting and hoping for approval by Day 180, sponsors who take advantage of Day-100 get a mid-course correction opportunity. By requesting the meeting early, coming prepared to discuss FDA’s feedback, and collaboratively planning how to address any issues, you greatly improve your chances of a first-cycle approval. This strategic checkpoint reflects a broader FDA philosophy of early engagement: as noted in FDA’s Q-Submission guidance, integrating such interactions “clarifies regulatory expectations… and ultimately reduces time to clearance.” For PMAs, where stakes are high and timelines long, that reduction in uncertainty is invaluable. Our team has guided clients through many Day-100 meetings, helping prioritize fixes and maintain a constructive dialogue with FDA. With the right approach, a Day-100 meeting is not just a formality – it’s a springboard to PMA success, ensuring that by the time Day 180 arrives, both you and FDA are on the same page for a positive decision.
