The US Food and Drug Administration (FDA) recently issued a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance — Questions and Answers — Draft Guidance for Industry and Food and Drug Administration Staff.” The Importance of this draft guidance is that, for the first time, the FDA is clarifying a 2012 change to its regulations that required all domestic and foreign device establishments to include information in their annual device listings on the 510(k) notifications covering the devices they market.

Transferring Ownership of a 510(k)

The draft guidance states that when a 510(k) is sold or transferred from one party to another, and the 510(k) device in question has not been significantly changed or modified, a new 510(k) submission for the transferred device is not required. In such a case, the draft guidance directs both device establishments engaged in the sale or transfer to notify the FDA of the transfer of 510(k) ownership by updating their respective electronic device registration and listing on the FDA’s Unified Registration and Listing System (FURLS). If the transfer results in the creation of a new device establishment, then the new establishment is required to register its establishment and list its devices with the FDA within 30 days of entering into operation. Any entity that fails to list its devices (and provide the necessary 510(k) information) renders the devices it markets misbranded.

These changes and those made in the 2012 regulations will now allow the FDA to track the 510(k) holder through FURLS based on the records submitted by device establishments. Furthermore, the FDA intends to link its 510(k) database to its FURLS system in the near future to provide the most up-to-date information to the public on the current 510(k) holder.

Disputes Over Who Owns a Particular 510(k) Notification

According to the draft guidance, if two entities claim to be the holder of a particular 510(k) notification, the FDA’s database will show the entity that listed its device most recently as the 510(k) holder until the issue is resolved. The FDA will then contact both entities and attempt to determine who the rightful 510(k) holder is. In the event of a dispute, a court order, attestation from a previous, uncontested 510(k) holder, legal instrument such as a contract or will, or other documentation of the sequence of historical transfers can be submitted as evidence in order to establish the facts and allow the FDA to make a determination of who the current 510(k) holder is.

CLIA Categorization

Since the FDA is also responsible for the categorization of commercially marketed in vitrodiagnostic tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the draft guidance further recommends that, when there is a change to the name of the cleared in vitro diagnostic device, or to the name of the manufacturer or distributor (via sale or transfer of the 510(k)), the device manufacturer should submit an updated device label to the FDA and update the appropriate 510(k) holder so that the Agency can ensure that the CLIA categorization for the device is accurate. The new 510(k) holder for the in vitro diagnostic test should also submit a “CLIA Categorization Update” letter to the FDA that identifies the 510(k) number for the device and provides a copy of the package insert that will be distributed with the device.

Interested parties may submit comments to the FDA on the draft guidance by March 23, 2015