Quick Answer
FDA registration renewal deadlines vary by product type. Food facilities renew biennially (Oct 1–Dec 31, even years). Drug and device establishments renew annually (Oct 1–Dec 31). MoCRA cosmetics registrations renew biennially. Missing any deadline can result in loss of registration and import detention.
Food Facility Registration (Biennial)
Under Section 415 of the FD&C Act and 21 CFR §1.230, food facility registrations must be renewed during the biennial renewal period: October 1 through December 31 of each even-numbered year.
Next Renewal: 2026
Window: October 1, 2026 – December 31, 2026
Who: All domestic and foreign food facilities registered with FDA
System: FFRM (Food Facility Registration Module) at access.fda.gov
Fee: No FDA fee for food facility registration or renewal
Food facilities that do not renew by December 31 will have their registration placed on inactive status. Foreign facilities with inactive registrations will have shipments detained at U.S. ports.
Drug Establishment Registration (Annual)
Drug establishment registrations under 21 CFR Part 207 must be renewed annually between October 1 and December 31. This applies to manufacturers, repackers, relabelers, and drug product salvagers of both prescription and over-the-counter drugs.
Renewal: Annual
Window: October 1 – December 31 (every year)
Who: All drug establishments (domestic and foreign)
System: DRLS (Drug Registration and Listing System)
Fee: PDUFA establishment fee applies for prescription drug establishments ($259,429 for FY2026)
Note that the Prescription Drug User Fee Act (PDUFA) establishment fee must be paid separately and is invoiced by FDA. Failure to pay the PDUFA fee will result in your registration being placed on hold.
Medical Device Establishment Registration (Annual)
Device establishment registrations under 21 CFR Part 807 must also be renewed annually between October 1 and December 31. The MDUFA V (Medical Device User Fee Amendments) annual registration fee must be paid before the registration takes effect.
Renewal: Annual
Window: October 1 – December 31 (every year)
Who: All device establishments (manufacturers, specification developers, contract manufacturers, etc.)
System: FURLS (FDA Unified Registration and Listing System)
Fee: MDUFA annual registration fee ($7,653 for FY2026)
MoCRA Cosmetics Registration (Biennial)
Under MoCRA (FD&C Act Section 607), cosmetics facility registrations must be renewed biennially. Facilities that registered in 2024 will need to renew in 2026. FDA is expected to announce the specific renewal window — likely July 2026 — but companies should prepare early.
Renewal: Biennial (First Renewal Expected 2026)
Window: Expected July 2026 (confirm with FDA)
Who: All cosmetics facilities registered under MoCRA
System: Cosmetics Direct
Fee: No FDA fee for cosmetics registration
Complete 2026 Deadline Calendar
| Product Type | Renewal Period | Frequency | Fee |
|---|---|---|---|
| Food | Oct 1 – Dec 31, 2026 | Biennial (even years) | Free |
| Drugs | Oct 1 – Dec 31, 2026 | Annual | PDUFA fee (~$259K) |
| Medical Devices | Oct 1 – Dec 31, 2026 | Annual | MDUFA fee ($7,653) |
| Cosmetics (MoCRA) | Expected July 2026 | Biennial | Free |
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