The proposed policy is intended to end long-standing confusion regarding how to track and update the ownership of 510(k)s.
The FDA does not require a new 510(k) when ownership changes. But while companies typically notify the agency when they acquire a cleared device, establishing an historical sequence of transfers for a particular 510(k) has been challenging, the guidance says.
Implementation of the FDA’s Unified Registration and Listing System Device Registration and Listing Module has changed all that, however. An offshoot of the 2007 FDA Amendments Act, FURLS DRLM provides a searchable online database of up-to-date 510(k) information. Devicemakers must register with the database and list the 510(k) numbers for all products they manufacture. When ownership changes hands, the old owner will delist the device and the new one will add its name and information.
If more than one company claims ownership of a 510(k), the FDA will contact all parties involved to determine the rightful owner, according to the guidance. The database will list the last company to enter information as the current owner while the FDA resolves the issue. Court orders, contracts, wills and other historical records may be submitted to support a case of ownership.
Owners of 510(k)s for in vitro diagnostic devices covered under the Clinical Laboratory Improvement Acts should submit updated labeling when the manufacturer or device name changes so that the FDA can ensure the CLIA categorization still applies.