By: Elle Winn (Mittal Consulting)

At 12:01 am ET on Wednesday, October 1, 2025, the US federal government began its government shutdown. With this shutdown, many are asking what it means for FDA operations, and especially the impacts on the medical device industry during this closure.

For the Center for Devices and Radiological Health (CDRH), most routine operations are halted during the shutdown until Congress restores funding¹. However, activities funded by the Medical Device User Fee Amendments (MDUFA) will proceed, supported by reserve funding which is expected to last for approximately 6-8 weeks^2-3.

Continued CDRH Operations Using Reserve Funding

While reserve funds last, the following CDRH activities will continue, though minor delays are possible:

• Ongoing reviews of submissions already received (including De Novo, 510(k), PMA, IDE, and Pre-Submissions)
• Enforcement actions for urgent health or safety issues
• Emergency recalls when significant public health risks emerge

Paused CDRH Operations

The following will be paused during the shutdown:

• No new medical device pre-market submissions will be accepted, as associated fees cannot be processed until the shutdown ends
• No new guidance documents will be issued
• Routine manufacturing facility inspections are halted, though for-cause inspections may proceed if health or safety risks are identified
• Most CDRH communications may be paused or significantly slowed

With regard to Pre-Submissions, new pre-subs may or may not be accepted depending on the workforce availability and reserve funding. Historically, submissions not requiring an associated user fee, like Pre-Subs or IDE applications, have been accepted during government shutdowns. However, plan for review delays with these processes, and keep in mind the possibility that CDRH may not be able to accept pre-submissions or IDE applications, depending on MDUFA reserve fund availability.

Manufacturer Impacts

Shutdown impacts for manufacturers vary depending on regulatory status:

• Those with ongoing reviews can expect relatively minor disruptions, as work funded by existing user fees proceeds at a limited pace while staffing and budgets adjust
• Manufacturers preparing for new submissions will see greater delays, since new submissions are not accepted during the shutdown.

It remains critical to maintain vigilance and regulatory compliance during the shutdown so that when CDRH resumes full operations, device manufacturer activities can proceed with minimal further disruption.

References:

1. US government shuts down, FDA closed for new applications. BioSpace. October 1, 2025. Accessed October 1, 2025. https://www.biospace.com/policy/fda-delays-likely-as-federal-government-hurtles-toward-shutdown.
2. Countdown to shutdown: Some CDRH operations would continue in funding freeze. Insights. Accessed October 1, 2025. https://insights.citeline.com/medtech-insight/policy-and-regulation/us-fda/countdown-to-shutdown-some-cdrh-operations-would-continue-in-funding-freeze-PUGGH2MGX5B6HHBFDJI5VRUM7M/.
3. What to expect when you are expecting…a government shutdown. FDA Law Blog. February 18, 2025. Accessed October 1, 2025. https://www.thefdalawblog.com/2025/02/what-to-expect-when-you-are-expectinga-government-shutdown/.