US Government Shutdown: FDA & Medical Device Impact

At 12:01 AM on October 1, 2025, the U.S. federal government officially shut down. For medical device manufacturers, this isn’t just a political event — it’s a regulatory disruption with real consequences.

FDA OPERATIONS

What’s Still Running, and What’s Not

The FDA is operating under its contingency plan, retaining approximately 86% of its staff thanks to user fee carryover and essential function designations. But that doesn’t mean business as usual.

Paused FDA Activities

No new medical device submissions: FDA cannot accept Q-sub, such as Presubmissions, 510(k), PMA, De Novo, or IDE applications.
Routine inspections halted: Standard facility inspections are suspended unless tied to urgent health risks.
New guidance documents delayed: Regulatory updates, including implementation support for recent guidance, are on hold.

Continuing FDA Activities

Reviews of existing submissions: If user fees were paid before the shutdown, review continues using the carryover funding.
Emergency recalls and adverse event monitoring: These remain active to protect public health.
Import surveillance: FDA continues screening medical products imported into the US.

Impact on Medical Device Manufacturers

The shutdown’s effects vary depending on where manufacturers are in the regulatory process:

Ongoing reviews: Expect minor delays, but most work continues under existing funding.
New submissions: Companies preparing new device applications must wait until the shutdown ends.
Facility inspections: Routine audits are paused, which may delay certifications or follow-up actions.
CSA implementation: The FDA’s final guidance on Computer Software Assurance (CSA) was released just days before the shutdown. While the guidance is active, any FDA engagement or clarification is now delayed.

HISTORICAL CONTEXT

What Past Government Shutdowns Tell Us

This isn’t the first time the FDA has faced a funding lapse. Here’s what history shows: Untitled design - 2025-07-29T221959.352

Duration of Shutdown: 16 Days

Impact on FDA & Healthcare: Routine reviews slowed, advisory meetings canceled. User fee-funded work continued.

Duration of Shutdown: 35 Days

Impact on FDA & Healthcare: Longest shutdown in U.S. history. FDA halted new submissions, creating a backlog that took months to clear.

Duration of Shutdown: Ongoing

Impact on FDA & Healthcare: FDA retains more staff than in previous shutdowns, but new submissions are paused, and guidance development is frozen.

The 2018–2019 shutdown cost the U.S. economy an estimated $3 billion in permanent GDP losses. For medical device companies, the backlog in approvals and inspections created months of delays in product launches and compliance activities.

Strategic Moves for Manufacturers During the Shutdown

While direct FDA engagement is limited, manufacturers can still make meaningful progress:

1st

Prepare submission packages:

Have documentation ready for when the FDA reopens.

2nd

Run internal audits and CSA pilots:

Use this time to validate systems like LMS or PLM.

3rd

Update SOPs and vendor contracts:

Ensure cybersecurity and change management visibility.

4th

Capture digital evidence:

Use system logs and audit trails to build objective records.

5th

Monitor FDA communications:

Stay alert for updates on reserve funding and operational changes.

CSA Guidance: A Timely Reminder

The FDA’s Computer Software Assurance (CSA) guidance, finalized on September 24, 2025, introduces a risk-based, least-burdensome approach to validating software used in production and quality systems. While the guidance is not the focus of this blog, it’s worth noting that CSA implementation may be delayed due to the shutdown’s freeze on new guidance support and FDA engagement.

Manufacturers should still move forward with internal CSA pilots and documentation, especially for systems like LMS, PLM, and reporting tools. When the FDA resumes full operations, having a CSA-aligned framework in place will accelerate compliance and reduce catch-up time.

Final Thoughts

Government shutdowns are disruptive, but they’re also temporary. For medical device manufacturers, the key is to stay proactive, maintain compliance, and be ready to move quickly when operations resume.

The FDA’s CSA guidance remains a powerful tool for modernizing software validation, but its rollout now competes with political gridlock. Whether this shutdown lasts days or weeks, the ripple effects will be felt across the industry.

To learn how your team can prepare your software validation for the eventual resumption of FDA operations, contact us for a free consultation.

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