A founder pulls up the FDA’s newly published review-time commitments and does the obvious thing. She pencils a 510(k) clearance ninety days after submission into her Series A model. Clean number, official source, right there in the agreement. Then someone who has filed before points at three small words: ninety FDA days. Not ninety calendar days. The distance between those two phrases is where a funding plan quietly cracks, and the draft agreement the FDA put out this month is worth reading closely, because most founders will read the wrong number in it.
What the FDA actually committed to
This month the FDA released the draft commitments letter for MDUFA VI, the medical-device user-fee agreement that sets review performance goals for fiscal years 2028 through 2032. The House Energy and Commerce health subcommittee held a hearing on the reauthorization on July 15, and public comment is open until August 7. As reported by attorneys at Holland & Knight, the draft keeps the headline timelines about where they have sat: 90 FDA days to decide 95 percent of 510(k) submissions, 150 FDA days for 90 percent of De Novo requests, and 180 FDA days for 90 percent of premarket approvals that skip an advisory panel. That is stability, not acceleration. For an early-stage founder, a predictable clock is easier to plan a raise around than a fast one, so hold the disappointment.
Read which clock it is
The runway math lives in the definition. An FDA day counts only the time your submission sits with the reviewer. The moment the agency issues an additional-information request, your file goes on hold and the clock stops. Every day you then spend running the extra test or rewriting the software documentation is a day that never touches the ninety. The FDA’s own performance goals spell it out that way. So the commitment is a promise about the agency’s working time, not about your calendar. Your calendar is set by something the agreement never names: how many of those hold-the-clock loops you trigger.
That count is not luck. It tracks submission quality, and submission quality gets decided long before you file. It is why I push founders to treat the pre-submission meeting as the real event. A pre-sub is not a question-and-answer session where you collect FDA opinions. You present a strategy, the predicates you plan to cite, the indication you plan to claim, the testing you plan to run, and the agency signals back whether it holds. The signal is rarely blunt. “You may be better suited to a De Novo” is not a suggestion, it is an answer, and a founder who files a 510(k) anyway after hearing it has just bought a stack of deficiency letters and all the paused-clock time attached to them. You put close to eighty percent of your eventual submission into that meeting for a reason.
The line worth watching
One item in the draft points somewhere useful. By the end of fiscal 2028, the FDA plans to run a pilot in which a device with the same intended use is submitted to the FDA and at least two other national regulators at the same time, with results published by September 2030. It is small, it is slow, and it will do nothing for anyone filing this year. But the direction matters to any hardware founder planning more than one market. Paying for the same certification twice in two jurisdictions is one of the quiet costs of regulated hardware, and it is not only a medtech tax. A grid-hardware startup clearing UL and its European counterpart pays it. So does a drone company answering to both the FAA and EASA. A regulator testing one submission read by three authorities at once is a small signal about where that cost drifts over the next decade.
Dave’s take
The founders who get hurt by a review clock are almost never surprised by the FDA. They are surprised by their own spreadsheet. They banked the official ninety-day figure, burned three review cycles fixing things they could have gotten right before filing, and watched a comfortable runway turn into a countdown. Read this commitments letter for what it is, a fixed cost you can budget for, as long as you budget against the right clock. The number you actually control is not the agency’s calendar. It is how clean the thing you hand them is on the first pass.
From Dave’s video library
Dave on making a confident call when the data is thin, the same discipline a founder needs when the one variable that sets the timeline sits on someone else’s desk.
I’m here to help you scale.
Work With DavePrefer a smaller first step? Book a $500 one-hour working session →
Dave Saunders is the founder of Base Reality Group and a Fractional CPO for hard-tech founders. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →