MedTech Regulatory Risk: Navigating the FDA During a Government Shutdown
When the U.S. government shuts down, the ripple effects reach far beyond Washington—especially for medical device companies whose regulatory timelines depend on the FDA’s day-to-day operations. Submissions pause, meetings are canceled, and uncertainty grows. But not every function stops, and understanding the distinction can help MedTech teams minimize disruption and even gain a strategic advantage.
In this episode of the Global Medical Device Podcast, Michael Nilo, NMCG’s President & Principal Consultant and former FDA Scientific Reviewer, joins host Etienne Nichols to discuss how shutdowns affect FDA activity—and how companies can prepare for and pivot through them. Drawing on his experience inside the agency and across the industry, Michael explains which FDA functions continue, which come to a halt, and what proactive steps manufacturers can take to safeguard their milestones, investor confidence, and patient-focused mission.
Below, we’ve summarized the conversation in a clean Q&A format, highlighting the most actionable insights for regulatory and executive leaders navigating this period of uncertainty.
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Etienne Nichols (Host):
When the U.S. government shuts down, what happens to the medical device industry—especially the FDA? It’s been 21 days since this shutdown began, and many companies are wondering: Are submissions frozen? Are contacts unavailable? What should MedTech leaders do right now to protect their timelines and runway?
Joining me today is Michael Nilo, President and Principal Consultant of Nilo Medical Consulting Group and a former FDA Scientific Reviewer. Michael has seen this scenario from both sides of the table—inside the agency and as a consultant to MedTech innovators around the world.
Q: Michael, what actually happens at the FDA during a government shutdown?
MN: I’ve gone through two shutdowns as a reviewer at the FDA. Initially, very little changes—until funding reserves start to run out. The FDA operates with a pool of user fees collected from companies under the Medical Device User Fee Amendments (MDUFA).
Essential FDA activities like active review of submissions already in-house, post-market safety surveillance, recall enforcement, and Investigational Device Exemption (IDE) reviews continue for a while using those reserves. However, new user-fee-supported submissions—like 510(k)s, PMAs, De Novos, and 513(g)s—cannot be processed during the shutdown.
If you submitted before the shutdown began, your review continues. But new applications are put on hold until funding is restored.
Q: Which activities slow down or stop completely?
MN: The biggest slowdowns occur in areas not tied to MDUFA goals or user fees—like Pre-Submissions (Q-Subs) and interactive reviews. These are considered “nonessential” when funding lapses.
Other activities that typically pause include:
Routine inspections and audits not tied to active PMA reviews
Development of new policy or guidance documents
Processing of Small Business Designation (SBD) applications
That last one—small business designations—is particularly concerning for startups. If you can’t get that designation processed, your user fees skyrocket once the FDA reopens.
Q: You mentioned MDUFA—can you explain what that is and why it matters here?
MN: Sure. MDUFA stands for Medical Device User Fee Amendments. It’s the system through which medical device companies pay fees for FDA review of their submissions. These user fees fund a major portion of the FDA’s operations.
When Congress doesn’t pass a budget, the taxpayer-funded portion of the agency stops—but the user-fee-funded part can continue temporarily. That’s what allows the FDA to keep certain critical functions running during a shutdown. It’s essentially a financial buffer that helps maintain continuity for safety monitoring and ongoing reviews.
Q: How does a shutdown impact companies preparing or submitting applications?
MN: For smaller companies, the impact can be significant. If you planned to submit a 510(k) or PMA during the shutdown, you can’t. Your corporate milestones shift, your cash burn continues, and your time to market gets delayed.
Equally important, the loss of interactive review—that back-and-forth communication between reviewers and manufacturers—slows the process even further once things resume.
That’s why I tell clients to plan for shutdowns like natural disasters. You can’t control them, but you can minimize the damage by timing submissions strategically.
Q: What should MedTech companies do while their submissions are on hold?
MN: Use the time wisely. I call this a forced pause for quality improvement. Here’s what I recommend:
Improve your submission quality. Make the document more navigable, better linked, and clearer. When the FDA reopens and faces a backlog, your submission will stand out.
Advance other workstreams. Redirect R&D, Quality, and Regulatory teams toward process validation, risk management file updates, and reimbursement planning.
Refine your commercial readiness. Use this time to strengthen your market access and launch strategies so you’re ready to move quickly post-clearance.
These activities keep your organization productive and can actually accelerate your market entry once reviews resume.
Q: What advice do you have for communicating with investors or boards during a shutdown?
MN: Be transparent and proactive. A shutdown is an “uncontrollable natural disaster.” Everyone in the industry understands the situation. Investors will be looking for signs that you’re using the downtime strategically—not sitting idle.
Show them that you’re strengthening your quality systems, refining your reimbursement plans, and doing everything possible to ensure that when the FDA comes back online, your company is first in line to move forward.
Q: From your experience, how long do shutdowns usually last—and how can companies plan ahead?
MN: Historically, most shutdowns last between two weeks and one month, though some have extended beyond 30 days. You can look at past budget cycles to predict risk periods.
If the next funding resolution expires March 1, for example, plan your submissions at least 30 days before that date. Build flexibility into your regulatory calendar. Assume the risk will recur and manage timelines accordingly.
Q: Any final advice for MedTech leaders navigating this uncertainty?
MN: Remember the mission. You’re building products that improve patients’ lives. The FDA’s staff share that mission, and many of them continue working through these shutdowns.
Stay focused, keep your teams productive, and treat the delay as an opportunity to make your product and your submission even stronger. When the lights come back on, you’ll be ready to move faster than the rest.
Etienne Nichols:
Michael, thank you for sharing your insights. This was an incredibly valuable discussion for anyone managing regulatory timelines during unpredictable government cycles.
To our listeners—if your investors, team, or partners are asking what’s next during the shutdown, this episode is a must-hear.
🎧 Listen to the full conversation: Global Medical Device Podcast — “MedTech Regulatory Risk: Navigating the FDA During a Shutdown”
Why It Matters—and How NMCG Helps
A government shutdown may be beyond your control, but its impact on your submission timelines, small business designation, and market entry strategy doesn’t have to be. At NMCG, our consultants—including former FDA reviewers—help device innovators develop contingency plans, refine submissions, and strengthen quality systems so that when operations resume, you’re ready to move forward without delay.
