October 10, 2025 – Update on FDA Lapse period of indefinite duration.
Content current as of November 10, 2025
The US government was shut down on October 1, 2025, as Congress and the Administration failed to agree on annual funding bills for federal agencies, including the DHHS and the agencies within it. Thus the FDA finds itself in a Lapse period of indefinite duration. FDA clarifies, that during the lapse period, the agency will be continuing vital activities, to the extent permitted by the law, that are critical to ensuring public health and safety in the United States.
At the same time, the Lapse will affect medical device regulatory activity in the following ways:
1. Medical device submissions requiring payment of user fees in F2026 (after Oct 1) will NOT BE accepted during the lapse period.
2. Review of open submissions for which fees were paid in F2025 will continue.
3. Presubmission meetings that were scheduled before the shutdown should continue as planned.
We recommend reaching out to your lead reviewers or program support agents to confirm dates/times or deadlines have not changed.
Some useful links:
- The official statement from the FDA
- A nice article from Regulatory Affairs Professionals Society (RAPS)
BML Health’s experience since October 1 has been the following:
- Open reviews have continued as scheduled;
- FDA is communicating, responding to emails and updating the CDRH portal as reviews and other activity continue. This has been reassuring;
- Previously scheduled pre-submission meetings are going on as planned, and lead reviewers and program managers are responding within the timelines;
- Lead reviewers and review teams have been reassigned on two of our open files (some of the staff has been furloughed, others it is unclear):
- In one case, we had a 510(k) submission cleared ahead of schedule, with significant proactive and regular communication from our newly appointed lead reviewer, a senior fellow.
- In another case, while we are expecting to be in a supplement discussion, our newly appointed lead reviewer seems to be starting from scratch, which may cause us further delays.
- We have not yet submitted any new Q-submissions since October 1, although we have several on deck: pre-submission meeting requests and Breakthrough Device Designation requests.
With a significant amount of staff currently furloughed, and no new submissions being accepted, it is unclear whether existing staff may actually have more time available for no-fee services, such as Q-submissions. It is also unclear whether submitting fee-based services, like premarket notifications, is advisable at this time, and whether it is best to get them into the queue as soon as possible, or to wait until the Lapse period ends to submit.
We will continue to keep you updated on the situation as news becomes available, and also as our own experiences unfold and we learn more first hand.
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