FDA Registration Renewal Season (October 1 – December 31)

FDA registration renewals for medical device and drug establishments run every year from October 1 to December 31. Food facilities renew in the same window, but only in even-numbered years such as 2026. Cosmetic facilities renew every two years. A registration that is not renewed on time is treated as expired.

Renewal calendar by program

Food facilities: October 1 – December 31 of every even-numbered year (21 CFR 1.230(b)). 2026 is a renewal year.
Medical device establishments: October 1 – December 31 every year (21 CFR 807.22(b)); pay the annual establishment fee first.
Drug establishments: October 1 – December 31 every year (21 CFR 207.29).
Cosmetic facilities: every 2 years under MoCRA (FD&C Act §607); product listings are updated each year.

What happens if you miss it

FDA considers a food facility registration that is not renewed to be expired and may remove it from the database (21 CFR 1.241).
Shipments from facilities without a valid registration can be held at the port of entry. In FDA import refusal data this often shows as registration-related refusal charges such as FRNMFGREG or NOT LISTED.
For devices, an establishment that pays the fee but does not complete the annual registration is not registered.

Checklist before October 1

Confirm your FURLS / ESG account and password still work
Check that your DUNS record address matches your registration
Confirm your U.S. Agent will accept the renewal and is ready to confirm
Device firms: pay the annual user fee and keep the payment identification number

Sources

General information, not legal advice. Last reviewed October 21, 2026.