21 CFR 207.29 · 807.22 · 1.230
FDA registration renewal: October 1 – December 31
Drug establishments (21 CFR 207.29) and device establishments (21 CFR 807.22) must renew FDA registration every year between October 1 and December 31; food facilities renew in the same window in even-numbered years such as 2026 (21 CFR 1.230). Device firms pay FDA's FY2027 fee of $13,785 first. Missing the deadline lets the registration lapse.
… left until the December 31 deadline (11:59 pm ET)
In FDA's public data, 10,563 drug and device establishments in our top 10 countries were still registered only through 2026 on 2026-10-22.
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FDA registration status checker
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- Device Agent $699/yr · Drug Agent $799/yr · Cosmetics Agent $590/yr
- Device registration & listing packet $290/yr · Drug renewal + no-change certification $199/yr
- Renewal Rescue: packet within 1 business day, $490
- Switching agents takes 1 day with no gap in coverage
What happens if registration lapses · FY2027 device fee · Blanket no-change certification