US Shutdown Ending Imminent: Now is the 'Golden Time' for FDA Renewal

Major foreign news outlets, including CNN, are reporting that the US federal government shutdown is finally nearing its end. While an official termination announcement has not yet been made, the normalization of government operations is imminent.

Once federal agency operations resume, medical device registration and renewal processes, which had been suspended, will fully restart. This period is historically the time when system delays and errors are most frequent, as companies worldwide simultaneously rush to access the system.

First Step After the Shutdown: FDA Medical Device Annual Registration Renewal

FDA medical device registration automatically expires at midnight (US time) on December 31st each year. To maintain registered status for 2026, the Annual Renewal must be completed immediately upon system resumption. To avoid submission delays or errors caused by system overload right after the shutdown ends, it is paramount to complete a pre-shutdown inspection before the shutdown is officially over.

Renewal Preparation Checklist: What to Check Now

• Test FDA Account (FURLS) Login

• Review Establishment Information

  • Verify Facility Name, Address, DUNS Number, Device Listing Number, etc.

• Prepare for Annual User Fee Payment (FY2026 Standard)

  • The OMUFA Fee sees a slight increase annually, and renewal is impossible before payment is completed.

• Confirm Status by Registration Role

  • Check that each role, such as Contract Manufacturer / Specification Developer / Initial Importer, is accurately reflected.

 Important Points Not to Miss

• Failure to renew will result in the automatic expiration of the Registration Number, making import and distribution within the US impossible.

• If products arrive in the US while the registration is expired, it can lead to Customs Hold for FDA Review or a Stop Sale order.

• Some brand owners must also ensure that the manufacturer or importer's registration has not expired.

Provision's FDA Renewal Support

Provision Consulting Group specializes in annually supporting the FDA Establishment Registration and Device Listing renewal for numerous overseas manufacturers and brands.

We meticulously monitor the anticipated system delays and regulatory schedules following the shutdown, providing practical, hands-on support to ensure each company can continue market distribution without any registration gap.

• Verification of renewal targets and review of submission documents

• Management of OMUFA payment and evidence

• Pre-inspection and correction support for registration/listing errors

• Monitoring and updating on the FDA system normalization schedule

When the US government shutdown ends, the renewal procedures for countless companies will converge on the FDA system within a short timeframe.

Now is the 'Golden Time' to get ahead and prepare before that congestion begins. Seemingly minor preparations—checking account status, verifying information consistency, and preparing fee payments—will make a significant difference in maintaining your FDA registration.

Provision Consulting Group is committed to prioritizing our clients' regulatory stability and market continuity, even after this shutdown, and strives to be your most trusted regulatory partner.

Please feel free to contact us with any questions or for assistance.

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