mdi Consultants, IncFDA Registration Renewal Opens October 1: Your Complete Prep Checklist
Every FDA-registered medical device establishment must renew its Establishment Registration between October 1 and December 31, 2026. There is no grace period. If your registration is not renewed by the deadline, it will expire on January 1, 2027, potentially resulting in shipment delays, import holds, or regulatory compliance issues.
The good news is that renewal itself is typically straightforward—provided your registration information is accurate and up to date. The best time to prepare is during Q3, giving you ample time to identify and correct any issues before the renewal window opens.
When does FDA registration renewal open and close?
The window is October 1 to December 31, 2026, annually. Renew inside it or your registration lapses on January 1. For foreign manufacturers, a lapse triggers an import alert and your product is held at the border.
Why You Should Prepare in Q3
Many companies wait until November or December to begin the renewal process, only to discover outdated information that requires additional time to resolve. Common issues include:
- Changes in company ownership or legal entity
- Incorrect establishment addresses
- Outdated device listings
- Changes in U.S. Agent information
- Missing or inaccurate UDI/GUDID records
- Payment delays during the busy renewal season
Reviewing these items now helps ensure a smooth renewal process and avoids unnecessary disruptions later in the year.
Your FDA Registration Renewal Checklist
| Item | What to Verify Now |
| Establishment Registration | Registration is active with the correct owner/operator and establishment address. |
| U.S. Agent (Foreign Manufacturers) | The designated U.S. Agent is current, responsive, and authorized to represent your company. |
| Device Listings | All commercially marketed devices are properly listed and discontinued products have been removed. |
| UDI / GUDID | UDI records are accurate and consistent with your current device listings. |
| Company Information | Any mergers, acquisitions, name changes, or address changes have been properly updated with FDA. |
| Registration Fees | Budget for the FY2027 FDA Establishment Registration Fee and confirm your payment process is ready. |
Why start in July instead of October?
Because every problem above takes time to fix. A US Agent who’s left the role, a product listing that never got updated, an ownership change that didn’t propagate — each can stall a renewal. Three months of runway turns a crisis into a checkbox.
What Happens If You Miss the Deadline?
Failure to renew your FDA Establishment Registration can result in:
- Expiration of your establishment registration
- Delays in importing products into the United States
- FDA import holds or shipment interruptions for foreign manufacturers
- Business disruptions while the registration is reinstated
Completing your review now significantly reduces these risks.
Who needs a US Agent for renewal?
Any establishment located outside the United States. The US Agent is FDA’s point of contact in the country — and one who doesn’t answer FDA is functionally the same as having none. Confirm yours is current as part of renewal prep.
MDI manages renewals for 35+ clients every year — no client deadline ever missed. Free registration-renewal review — we audit your file in July so October is effortless.