I have heard this phrase in almost every deal involving a device still working through FDA clearance. It sounds reassuring on its own. It rarely tells you much.
Two very different situations, one reassuring phrase
"On track" can describe a submission that went in on schedule, with FDA still in its standard review window and no word back yet. It can also describe a submission that already received an Additional Information request, where the company is in the middle of preparing its response. Both of these get reported internally as "on track." The timeline behind each one, and the risk that goes with it, are not close to the same.
A deal team hearing "on track" for the first time has no way to tell which situation they are in unless they ask.
The classification changes the clock
Part of the confusion is that "on track" gets used the same way regardless of pathway, and the pathways do not run on the same clock. A 510(k) runs on a roughly 90-day FDA review goal, and an Additional Information hold pauses that clock entirely. If the hold runs past 180 days without a response, the file can be considered withdrawn and has to be refiled from scratch. A PMA runs on a much longer standard, closer to 180 days and often more in practice, with its own form of an Additional Information request plus the possibility of a formal major-deficiency letter and, for some products, an advisory panel meeting. "On track" has to be read against whichever clock actually applies. A status update that does not say which pathway it is describing is already missing the detail that matters most.
Four things worth verifying directly
These are the questions I ask when a regulatory status update is part of a diligence package:
- Read the actual correspondence. Ask for the FDA letters themselves, not a summary of them written by the regulatory team. A summary tells you what someone concluded. The letter tells you what FDA actually asked.
- Get a real date on every open item. If there is an Additional Information request, every item in it should have a status and a specific date for when it closes, not a general estimate for the submission as a whole.
- Check the review-cycle assumption in the model. Find out whether the timeline the deal model relies on assumes the fastest possible FDA review cycle, or a realistic one based on recent history for this product category and this review division.
- Ask about the next round, not just this one. A regulatory team can have a solid plan for a clean first review and still have no plan for a second round of questions. Scale-up and launch timelines usually assume the first plan worked.
Why the gap matters before close, not after
A regulatory status line written for a board slide and a regulatory status line written for the people actually closing the deal should say the same thing. In my experience, they usually do. When they do not, the gap is almost always a difference in what counts as "on track," and it is far cheaper to understand that difference before the signature than to discover it in the first board meeting after close.
What's the regulatory status claim you've learned to verify yourself instead of taking at face value?
Chris Steadham is the founder of Truestead Advisors and has spent 30+ years in medical device product development, manufacturing scale-up and general management. Working through a regulatory timeline on a live deal? Start a conversation.