Understand the full FDA Pre-Submission process—from acceptance review to meeting scheduling, written feedback, and follow-up—so you can plan effectively, avoid delays, and align your development timeline.
When you send a Pre-Submission request to the FDA, a defined process kicks off with set timelines. Knowing what to expect and when will help you plan your project and follow up appropriately. Below is an overview of the typical Pre-Submission timeline from submission to final feedback:
“Day 0” is when your Pre-Sub package is received by the FDA. From that point, the FDA will perform an acceptance review within 15 calendar days. During this phase, they check that your submission is complete and meets the criteria (using the Pre-Sub Acceptance Checklist). If anything is missing or the request is not eligible as a Pre-Sub, FDA can put your submission on hold (Refuse to Accept) and notify you of the deficiencies. You’ll then need to provide the missing information; once you do, the 15-day clock restarts and FDA will review again. If your package is complete, FDA “accepts” the Pre-Sub and assigns a lead reviewer (you will get their contact info in the acceptance notice).
If you requested a meeting (as opposed to written feedback only), FDA will start coordinating scheduling upon acceptance. They try to accommodate one of the dates you proposed in your cover letter, if possible. Typically, Pre-Sub meetings are targeted for about 70–75 days after FDA received your submission. The FDA’s goal is to finalize a meeting date relatively early – ideally within 30 days of the clock start (acceptance). If none of your proposed dates work or scheduling is difficult, they will offer alternative dates (still aiming for before day 75). In fact, if a meeting date isn’t agreed by day 30, an FDA manager will step in to help resolve scheduling by around day 40. For planning purposes: expect your meeting roughly 2 to 2.5 months after your request. (If you chose written feedback only, you can ignore this step – no meeting will be scheduled.)
The core of the Pre-Submission is FDA’s feedback on your questions. The FDA commits to providing written responses by about 70 days. Specifically, if you did not request a meeting, FDA will send you written feedback within 70 days of receiving your Pre-Sub. If a meeting is scheduled, FDA will send you preliminary written feedback at least 5 days before the meeting (and still no later than 70 days). In practice, sponsors often receive an email with a written “FDA Preliminary Feedback” document outlining answers to each question. This gives you time to review their answers in advance. Many sponsors are pleased to find that this early feedback addresses most of their questions; if so, you even have the option to cancel the meeting if you feel it’s no longer necessary (and simply accept the written answers as the final feedback).
If you requested an interactive meeting, it will typically occur around the 70- to 75-day mark (about 10 weeks after submission). Meetings are usually one hour long. They can be held in-person at FDA headquarters or more commonly via teleconference or videoconference, allowing you and your team to discuss FDA’s feedback with the reviewers directly. The meeting is your chance to ask follow-up questions, clarify any ambiguous responses, and ensure you fully understand FDA’s position. It’s not the time to make a sales pitch or introduce extensive new data – use it to resolve doubts on the feedback you’ve already received. FDA will have a roster of their team (review staff, branch chiefs or specialists as needed) on the call. You should have your subject matter experts on the line as well, in case technical details need discussing. (In a later section, we’ll go deeper into meeting types and best practices.)
After the meeting (or after receiving written-only feedback), the Pre-Sub process concludes with some formal wrap-up steps. The sponsor is expected to draft meeting minutes within 15 days and send them to FDA. If it was written feedback only, you might not need minutes; but for any discussion meeting, minutes are important. FDA will review your minutes and either concur or suggest edits. Once any edits are resolved, the minutes become the official record of the meeting. These minutes, along with FDA’s written feedback, are critical documentation that you’ll use moving forward. You should also begin executing on what was learned – for example, adjusting your testing plans or gathering additional data that FDA indicated would be needed for your eventual submission. (We cover post-meeting best practices in a later section as well.)
Throughout this timeline, it’s worth noting that Pre-Submissions are free of FDA user fees (unlike many formal submissions). The main cost is your time and effort to prepare the package and respond. The overall elapsed time from submission to final feedback is typically around 2–3 months, which in most cases is time well spent if it prevents delays during the formal review of your device.
Keep in mind that these are general timelines under the FDA’s performance goals – actual timing can vary slightly based on FDA’s workload and the complexity of your questions. However, the FDA’s MDUFA V commitment has put these timeframes into guidance to ensure sponsors get timely responses. By understanding the timeline, you can synchronize your development schedule accordingly (for example, perhaps running certain tests in parallel while waiting for feedback, but holding off on irreversible decisions until the Pre-Sub feedback is in hand).
