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What Happens If FDA Registration Lapses?

If a drug establishment does not renew between October 1 and December 31 (21 CFR 207.29), its registration expires and it drops from FDA's Drug Establishments Current Registration Site; listings tied to expired establishments are inactivated. A device establishment that misses renewal is treated as having failed to register (21 CFR 807.22). Imports can be refused as misbranded.

Drugs

  • Registration expires and leaves the current registration list
  • FDA inactivates listings linked to expired establishments (each July) and listings not updated or certified (each January)

Devices

  • Missing the annual window means the establishment has failed to register (21 CFR 807.22)
  • The annual establishment fee must be paid before registering

Fix it

  • Renew as soon as possible; our Renewal Rescue prepares the packet within 1 business day ($490)
  • Make sure the U.S. Agent confirms the designation

Related: FDA renewal deadline calendar · Do I need a U.S. Agent? · US Agent Desk pricing

Sources

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