Annual FDA Registration Renewal: How to Get Through Oct–Dec Without Surprises
Between October 1st and December 31st of every year, every medical device establishment—domestic or foreign—must renew its FDA registration. For many companies, this is a chaotic scramble of credit card payments and password resets. For BRS clients, it is a structured governance checkpoint.
Renewal is not just about paying the User Fee (MDUFA). It is a legal attestation that your registration data is current and accurate. Simply paying the fee without reviewing your listings is a missed opportunity to reduce risk and save money.
The Renewal Checklist
1. Verify the Official Correspondent: FDA accounts often list former employees as the primary contact. Renewal is the time to update this to a generic email or a current stakeholder to ensure you receive renewal notices.
2. Prune the Portfolio: Are you paying to list devices you discontinued in June? Are you listing a facility you closed in August? Renewal is the best time to deactivate dormant listings and close facilities, potentially simplifying your inspection profile.
3. Confirm the U.S. Agent: For foreign sites, you must re-confirm your U.S. Agent. If your Agent does not affirmatively accept the designation in the FURLS system, your renewal will not process, even if you paid the fee.
The Consequences of Failure
If you fail to complete the renewal process by December 31st, FDA considers your products misbranded. Your registration status changes to "Inactive" on January 1st. This triggers immediate holds on any shipments entering the U.S. and can alarm hospital procurement departments who monitor the FDA database for vendor compliance.
The BRS Governance Model
- Proactive Planning: We start the renewal conversation in September, issuing fee guidance so your finance team can prepare.
- Listing Review: We circulate your current listing data for verification before locking it in for the next year.
- Execution Certification: We process the payment, perform the FURLS update, and provide a "Certificate of Registration" (or equivalent confirmation) for your records.