The U.S. federal government is now in a shutdown, effective October 1, 2025. Below is what the MedTech community should know — and how to keep perspective through the disruption. Good news? Most of the existing MedTech review work is funded by user fees, and as a result, the FDA has a bit of cushion to continue their critical work even during this time. In this post we break down what is, and isn’t, impacted during this time, and what history tells us about what is likely to occur next.

What FDA Can (and Will) Continue Doing

• While Pre-submissions do not have user fees tied to them, they generally progress as staff working on these submissions do not tend to be furloughed. Note that face-to-face meetings may be delayed though.

• Review of existing submissions funded by user fees (e.g. devices, biologics) may continue as long as carryover fee funds remain.

• Respond to urgent safety actions: recalls, drug/medical device shortages, public health emergencies, and “for-cause” compliance or inspection activities.

• Address import entry reviews, emergency field actions, and critical enforcement activities.

• Maintain functions funded outside of annual appropriations (like tobacco regulation) or critical public health mandates.

What’s Likely Paused or Limited

• Acceptance of new user-fee submissions (e.g. new 510(k)s, new PMAs, De Novos) is generally suspended during funding lapses. (Although submissions will be placed in the queue),

• Routine inspections, especially non-critical ones, will be deferred (unless there is a significant safety signal).

• Development work, nonessential regulatory science, hiring, routine communications, policy development, and discretionary projects may be paused or slowed.

• Some back-and-forth interactions or minor correspondence may lag significantly, depending on the availability of personnel.

Key Considerations & Protections

• Under the Government Employee Fair Treatment Act of 2019, federal employees who are furloughed (or working without pay, if excepted) are entitled to back pay once the shutdown ends.

• If the shutdown is relatively short-lived, the impacts will be less likely to impact the medical device industry.

• The shutdown is by nature temporary. Once funding is restored, paused activities typically resume (often with backlog catch-up).

• The MedTech community has experience navigating these lapses, and perseverance is key.

Perspective Matters
While delays and disruptions are real, history shows shutdowns are temporary. The MedTech community continues to innovate and serve patients even when regulatory timelines shift.

At indieMedTech, we believe in keeping perspective: this is a roadblock, not a dead end. Patients still need access to life-saving treatments, and our community knows how to persist.

Have questions about your submission or project status during this shutdown? Want to strategize around timing? Drop us a note or join the discussion — we’ve got FDA experts ready to assist!