Between October 1 and December 31 every year, FDA-registered facilities around the world must submit renewals to their registrations (except registered food facilities, which must renew every even-numbered year). If your facility is registered with FDA, then this applies to you!
To properly renew your registration:
- Registered medical device establishments
- pay the annual Device Facility User Fee
- receive back from FDA the Payment Identification Number (PIN) and Payment Confirmation Number (PCN)
- review/update all the information currently in your account, and then confirm accuracy through the Device Registration and Listing Module
- Registered drug facilities
- review the information in the most recently submitted Establishment Registration file
- submit either an updated registration file or a no-change notification, as appropriate, through the Electronic Submissions Gateway
- Registered tobacco facilities
- review/update the information in the most recently submitted registration file
- re-submit the file to FDA through the Tobacco Registration and Listing Module
- Registered food facilities
- do not need to renew at this time
- may need to update registration information if anything has changed
- may also need to renew agreements with U.S. Agents, as these are often made on a per-year basis
Non-renewed registrations will be deemed inactive or invalid by FDA, who will reach out to those facilities to confirm that they are no longer handling FDA-regulated products. If FDA receives no response, then FDA will delete the registration and the facility will be considered unregistered. Any shipments from unregistered foreign facilities or to unregistered domestic importers may be held at the port of entry. For assistance with your renewal, contact us today.
