At Last, FDA Issues (Draft) Guidance on 510(k) Transfers

By Jeffrey K. Shapiro –

FDA has always allowed companies to transfer 510(k) clearances without obtaining new clearance.  Indeed, this blogger provided a short primer on the topic 15 years ago.  However, this administrative practice has long been shrouded in mystery, because FDA has never published guidance.

Until now!  At last, FDA has issued a draft guidance in the form of a Q&a on 510(k) transfers.  The Federal Register notice can be found here.

The key points:

FDA allows allows a 510(k) holder to transfer clearance without a new 510(k) clearance (absent a significant modification of the device).  There may be only one 510(k) holder at a time. 

Notice of a 510(k) transfer is (and always has been) accomplished via compliance with device listing requirements.  The transferor notifies FDA by de-listing the device, and the transferee notifies FDA by newly listing the device.  Although the regulations only require an update annually, the federal register notice for the draft guidance estimates that 78% of listing updates are voluntary changes outside the annual registration cycle.

FDA has never had the capability to track 510(k) transfers through each iteration, and it still does not.  What is new is that, for the first time, FDA has developed the ability to show the current 510(k) holder (as opposed to the original 510(k) holder) in the 510(k) clearance database.  This capability has arisen because registration and listing regulations were altered in 2012 to require the 510(k) number associated with each device to be listed in FDA’s Unified Registration and Listing System (FURLS) Device Registration and Listing Module (DRLM).  Taking advantage of this requirement, FDA has modified the 510(k) clearance database to sync with the FURLS DRLM so that the most recent 510(k) holder can appear in both databases.

Because FDA does not track 510(k) transfers, it is possible for ownership to be disputed.  Interestingly, the federal register notice estimates there are approximately 2,000 such disputes per year, with an average of 2.3 parties involved (meaning that a good percentage of these disputes involve more than two parties).  (This blogger’s primer has some tips on how 510(k) purchasers can mitigate this risk.) 

If two persons claim to be the 510(k) holder, based upon conflicting listings, the draft guidance indicates that FDA will contact both parties and attempt to determine the rightful 510(k) holder.  This willingness to intervene may be a new development, since in our experience FDA generally has shied away from involvement in these disputes. 

The guidance does not provide procedural detail about how the dispute resolution process will be conducted.  (It would be helpful if the final guidance did so.)  The draft guidance does give examples of the type of documents that might be submitted to prove ownership:  court orders, attestation from a previous uncontested 510(k) holder, a legal instrument (e.g., contract or will), and/or other documentation establishing the chain of transfers up to the current holder.  A contest over ownership could be high stakes if both purported 510(k) holders are actively placing a device in commercial distribution under the same K number: the loser’s device will be deemed misbranded.

The draft guidance explains that a number of different parties may need to list a particular 510(k) number, in their role as manufacturer, specification developer, repacker/relabeler, single use device reprocessor or remanufacturer of a device.  Furthermore, after the 510(k) holder has listed, under secondary parties are expected to list their customer’s 510(k) number (contract manufacturers, sterilizers, foreign exporters, and foreign private label distributors).  The draft guidance does not explain how FDA will distinguish the 510(k) holder from others required to list the same number, but presumably these distinctions will be drawn based upon the activities of the listing party (e.g., if a sterilizer lists the 510(k) number, FDA will infer that it does not claim to be the 510(k) holder).  It would be helpful if the final guidance addressed this topic more clearly.

Finally, the transfer of a 510(k) relating to an in vitro diagnostic (IVD) test raises an additional issue.  FDA is responsible for categorization of commercially marketed IVD tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  The draft guidance indicates that where the name of a cleared device changes, or the name of the manufacturer or distributor changes, an updated label and copy of the package insert should be submitted to ensure accurate CLIA categorization and record of the 510(k) holder and device information.  This recommendation is a bit of a trap, because FDA may take the opportunity to consider changes to the test since clearance, and the new 510(k) holder may be required to provide a new CLIA and/or 510(k) submission.  Nonetheless, it is difficult to see how to avoid it, since failure to do so will mean that the CLIA categorization database does not list the new 510(k) holder.