Why Renewal Deadlines Matter
FDA registration is not a one-time event. Every FDA-regulated facility must renew its registration on a set schedule — and missing that window can result in your registration lapsing, which means you can no longer legally import or market your products in the United States until the registration is renewed.
Importantly, the FDA does not send automatic renewal reminders to registered facilities. It is your responsibility (and your U.S. Agent's) to track renewal windows and file on time.
Complete Renewal Calendar by Product Type
🌿 Food Facility Registration (Bioterrorism Act / FSMA)
Renewal Schedule
- Frequency: Every 2 years (biennial)
- Renewal Window: October 1 – December 31 of even-numbered years
- Next renewal window: October 1 – December 31, 2026
- After that: October 1 – December 31, 2028
- Consequence of missing: Registration canceled; facility cannot export food to the U.S.
🩺 Medical Device Establishment Registration
Renewal Schedule
- Frequency: Every year (annual)
- Renewal Window: October 1 – December 31, every year
- Next renewal window: October 1 – December 31, 2026
- Consequence of missing: Registration lapses; import violations and import alerts may follow
💊 Drug Establishment Registration
Renewal Schedule
- Frequency: Every year (annual)
- Renewal Window: October 1 – December 31, every year
- Drug listing update: Also required at the same time — report any discontinued products
- Consequence of missing: Registration lapses; facility cannot legally manufacture drugs for U.S. distribution
✨ Cosmetic Facility Registration (MoCRA)
Renewal Schedule
- Frequency: Every 2 years (biennial)
- Renewal Window: Aligned with registration anniversary — FDA is finalizing the specific renewal structure
- Product listing update: Must be updated if any product information changes
- Consequence of missing: Non-compliant status under MoCRA; subject to FDA enforcement
2025–2026 Key Dates Summary
- October 1, 2025: Annual renewal window opens for medical devices and drugs
- December 31, 2025: Annual renewal window closes for medical devices and drugs
- October 1, 2026: Annual renewal window opens for medical devices and drugs; biennial window opens for food facilities
- December 31, 2026: ALL product types — renewal deadline (food biennial + devices annual + drugs annual)
What Happens If You Miss a Renewal Deadline?
If you miss the renewal window, your registration automatically lapses at the end of the registration period. To resume marketing or importing:
- For food facilities: You must submit a new registration (treated as a new registrant)
- For drug establishments: You must submit a new registration and pay applicable fees
- For medical devices: You must re-register and re-list all devices
- Any shipments attempted during the lapsed period may be refused at the border
Regovant Renewal Management
As your U.S. Agent, Regovant monitors your registration status year-round and sends renewal notifications 90, 60, and 30 days before each renewal window opens. We process your renewal submission automatically as part of our annual U.S. Agent service, ensuring you never miss a deadline.