Keep your FDA registration and device listings current. Learn how to update ownership, company name, address, contact personnel, add new devices, or modify existing listings to maintain compliance and avoid enforcement or import issues.
Businesses aren’t static – companies get acquired, names change, facilities relocate, and product lines evolve. When such changes occur, it’s crucial to update your FDA establishment registration and device listings to reflect the current information. FDA regulations require timely updates so that the registration database remains accurate. Here’s how to handle common scenarios:
If your medical device business is sold or merged, resulting in a new owner/operator for the establishment, the FDA considers that a transfer of ownership that impacts registration. The new owner cannot simply continue under the old owner’s FDA registration indefinitely. Instead, the new owner must register the establishment under their own ownership within 30 days of the change (per FDA’s policy and industry practice). In practical terms, this means the new owner will create their own FURLS account (if not existing) and submit a new registration for the establishment, obtaining a new owner/operator number. FDA’s FURLS has a feature called “Transfer Ownership of Facility” to facilitate this. The new registration will reference the previous registration number during the transfer process, effectively informing FDA that ownership changed. All device listings can be transferred over to the new owner’s account, so you don’t have to re-enter all device information.
For example, if “ABC Medical Inc.” (owner) sold its manufacturing plant to “XYZ Corp” on January 1, 2025, then by end of January, XYZ Corp should login and register that plant under XYZ’s ownership. ABC would no longer list that establishment after the transfer. If this isn’t done, then come the next annual renewal, the registration could lapse or there could be confusion over who is responsible.
If your establishment’s name changes (even without a change in actual ownership) or your physical address changes (you move to a new location), you must update FDA. A name change might occur due to rebranding or corporate restructuring. An address change obviously happens if you move or add locations. FDA needs to have the current name and address in the database; otherwise, any FDA correspondence, inspections, or import checks could be misdirected.
To update these, you would log in to FURLS, go to the Account Management or Facility Information section, and edit the establishment record. There is an option to “Change Registration Information for a Facility” in FDA Industry Systems. Here you can edit things like the establishment name, address, and contact info. FDA does not require a completely new registration for a mere name change or address change (as long as ownership remains the same), but you do have to report the change. Ideally, this should be done within 30 days of the change. At the very latest, it must be caught during the annual registration renewal – but from a compliance standpoint and to avoid confusion, it’s best to update immediately when the change occurs.
Example: If you were “ABC Medical Inc.” and you officially rename to “ABC MedTech Inc.”, you’d update the name in FURLS so that your registration now shows the new name. If your factory moves from 100 Main St to 500 Elm St, update the address as well. These updates ensure, for instance, that an FDA inspector doesn’t show up at the wrong location based on old information or that import entries (which often use the registration database) don’t get flagged because the addresses don’t match.
Changes in personnel for regulatory contacts also need updating. The Official Correspondent is the person FDA will email for all matters about your registration. If that person leaves your company or their email changes, you should assign a new official correspondent in the FURLS account settings promptly. Similarly, for foreign firms, if you change your U.S. Agent, you must update that in FURLS and the new agent must confirm. FDA requires that changes in U.S. Agent be reported within 10 business days, reflecting the importance of having a reliable U.S. contact at all times. A quick update in the system (and the agent’s confirmation via email) will take care of it.
If you start manufacturing or distributing a new device that wasn’t previously listed, you need to add a new device listing. This is done by logging into FURLS, selecting your establishment, and choosing the option to add (create) a listing. Provide the product code, name, and any 510(k)/PMA number as required, just like you did for initial ones. FDA expects that whenever a new device enters commerce, it should be listed within 30 days of that initiation. For example, if you begin selling a new model in June, don’t wait until the October annual update – list it in June or July soon after launch. This way, any FDA database checks (for instance, if an import of that device occurs) will find the device listed.
What if something changes about a device you already listed? Common scenarios:
If a device is temporarily off-market (say you paused distribution but might resume), FDA allows you to list that a device’s commercial distribution was “ceased” on a certain date, and later you can update to resume distribution by providing a resume date. This is more relevant for if FDA or you voluntarily halted a product and then restarted – it keeps the history transparent.
If your establishment goes out of business or stops all device manufacturing, you should officially de-register it. You can log in and choose to deactivate the facility registration (especially during annual renewal, just don’t re-register it). However, if an establishment simply doesn’t renew by Dec 31, FDA will automatically list it as expired. It’s better, though, to formally indicate the cessation of operations via an update or by contacting FDA, so that it’s clear you didn’t just forget. This can avoid FDA attempting to follow up or inspect a site that no longer exists.
Always keep documentation of the changes you submit. After you update something in FURLS, it’s wise to save a PDF of the confirmation or take notes of what was changed and when. If any questions arise (for example, an FDA inspector might ask “when did you update your address in the system?”), you have a record.
FDA uses the registration data actively – for scheduling inspections, for import screening, for emergency contact if there’s a safety issue, etc. If you don’t update: – The wrong facility might get inspected (or you might miss an inspection notice entirely if mailed to old address). – Import shipments could be detained because the listing info doesn’t match the shipping documents (e.g., the label shows Manufacturer at “500 Elm St” but FDA’s data still has “100 Main St” – this discrepancy could raise a flag). – If ownership changed and FDA isn’t aware, enforcement actions or legal documents might target the wrong entity. Also, the new owner might not realize they need to pay the annual fee (if they assumed it was already handled), leading to lapses. – In the case of foreign firms, not updating a U.S. Agent could mean FDA can’t reach you in urgent situations (like a recall or import alert), which could escalate problems.
The good news is FDA’s system is available year-round for updates. All owners/operators can access FURLS any time throughout the year to update changes as those changes occur. You don’t have to (and shouldn’t) wait for the yearly renewal window to make critical updates.
In summary, whenever a significant change occurs in your establishment’s details or device roster, make it a priority to update your FDA registration/listing promptly. It keeps you in compliance and avoids the potential compliance risks and business interruptions that outdated information can cause. If you’re unsure how to record a particular change (some situations can be tricky, like partial transfers of product lines), FDA’s Registration and Listing helpdesk (reglist@cdrh.fda.gov) can provide guidance, or consult a regulatory professional. Keeping your FDA records current is as important as initial registration – it’s part of the lifecycle of compliance.
