The cheapest meeting a startup will ever have with FDA is free, takes 70 days, and pays for itself if you ask the right three questions. Here is what goes in the package and how the clock runs.

A Pre-Submission is a formal written request for FDA feedback before you file. FDA answers in writing, and if you ask, in a meeting after the written feedback. The program is voluntary and carries no user fee. FDA's own guidance says feedback "is most effective when requested prior to execution of planned testing," which is the whole point: find out what the reviewer wants before you spend the bench and clinical budget on the wrong thing.

What a Pre-Sub is for, and what it is not

Ask specific questions about a planned 510(k), De Novo, PMA, IDE or similar submission: testing protocols, the data needed, whether a cleared device can serve as a predicate. Common topics include bench testing, biocompatibility, software, cybersecurity, clinical endpoints and statistical plans.

Three things a Pre-Sub is not. It is not a pre-review of your submission. It is not a pre-review of data, though you can ask how to interpret a difficult preliminary result. And it is not the place to ask what your classification and regulatory requirements are; that question is a 513(g) Request for Information, which does carry a fee.

FDA feedback does not bind you, but a later submission that takes a different approach should explain why. It also does not guarantee a favorable decision, and new questions can appear when the full submission is read as a whole.

The clock

FDA's goals, from Table 1 of the May 2025 guidance:

  • Written feedback only: 70 days from receipt.
  • Written feedback plus a meeting: written feedback at 70 days or 5 days before the meeting, whichever is sooner; the meeting itself typically lands on day 70 to 75.
  • Submission Issue Request (for discussing a hold or deficiency letter): 21 days if the request arrives within 60 days of the letter, 70 days after that.
  • Informational meeting (you present, FDA listens): 90 days.

The review clock starts when a valid eCopy or eSTAR submission is received. Submit through the CDRH Portal. There is a voluntary eSTAR template for Pre-Subs, called PreSTAR.

What goes in the package

The cover letter needs the basics: contact information for the submitter and any consultant, the Q-Sub type, the feedback method you want, and if you want a meeting, a draft agenda with time estimates, the format, three or more preferred dates, and the planned attendees with titles. Suggest the FDA expertise you want in the room. If your questions involve statistics, ask for a statistician.

The body should make five things easy to find:

  • Purpose. What you want out of the interaction.
  • Device description. How it works, the science behind it, the significant physical and performance characteristics, and a brief note on manufacturing if manufacturing could affect safety. Name the specific parts of the device the questions are about.
  • Proposed indications for use. The condition, the population, and the structure or function affected. Feedback depends on this, so do not leave it vague.
  • Regulatory history. Every prior FDA interaction on the device, with submission numbers, the feedback received and how you resolved it.
  • Planned follow-on submission. Say whether the questions are aimed at a 510(k), a De Novo, an IDE or something else, so FDA can direct the feedback.

Include enough background for FDA to answer: literature, engineering drawings, proposed labeling, redlined protocols. Then stop. The guidance is blunt that "submission of extraneous information can be counterproductive." If you need a lot of background, say which parts relate to which question.

The questions

This is where most Pre-Subs are won or lost. FDA has "found it difficult to address more than 3-4 substantial topics in a single Pre-Sub," where a substantial topic is a focused area of expertise: bench performance, biocompatibility, an animal study, software, sterility and shelf life, clinical endpoints, a statistical plan, a PCCP. The most effective Pre-Subs "typically have no more than 7-10 questions (including sub-questions)," split across those topics.

Make each question specific and answerable, and give your own position on it. FDA will not design your study, so if you want protocol feedback, send a proposed outline with a rationale and ask directed questions about it. Watch for dependencies: performance testing questions depend on the indication and the pathway, so settle those first or ask about them first and come back for the rest in a supplement.

If you have too many topics, FDA may call to ask which ones to prioritize. It is better to make that call yourself and file the rest as a second Pre-Sub.

The meeting

Meetings are normally one hour and virtual is easiest to schedule. FDA comes prepared to discuss the package and its written feedback, not new material you send in between. Draft slides go to FDA at least two days before.

You take the minutes. Say so at the start and end of the meeting, then submit them as an amendment within 15 days. Summarize the discussion, how issues were resolved, and the action items, attributed to FDA or the submitter rather than to individuals. If FDA edits them, it aims to send the revision within 30 days, and the minutes become final 15 days after that unless you flag a disagreement. The FDA-generated minutes are the official record. Do not record the meeting.