FDA issues guidance on transferring 510(k) ownership

The US Food and Drug Administration (FDA) recently released a draft guidance that clarifies the responsibilities of new owners of 510(k) clearances when products are sold or transferred to another entity.

The guidance, which was issued in a question-and-answer format, also addresses when a new 510(k) is required. Companies are only required to submit a 510(k) if the device is about to be “significantly changed or modified in design, components, method of manufacture, or intended use.”

The guidance states that when a 510(k) clearance for a specific device is sold or transferred from one person to another, the new 510(k) holder must list their device in the FDA Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM), within 30 days of the transfer.

The transfer of a 510(k) clearance may also require label updates, including updates to the name and place of business of the manufacturer, packer, or distributor. The new owners must also ensure that the label bear a unique device identifier (UDI). The labeler must submit an update to the Global Unique Device Identification Database (GUDID) if the name of the labeler has changed.

FDA states in the guidance that there can be no more than one 510(k) for a specific product. “Because there can only be one entity proposing to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device, FDA believes there can be only one 510(k) holder for a device at a time.”

If an entity fails to register, list, update GUDID information, or submit a marketing application, their device might be considered adulterated or misbranded.

The guidance notes that contract manufacturers, sterilizers, repackagers, and labelers must list the device using the FDA-assigned 510(k) number of the cleared 510(k).

FDA said companies should not expect the agency to handle information regarding ownership transfers. “FDA commonly receives requests from individuals noting that a 510(k) clearance has been transferred to that individual from a previous 510(k) holder, and asking FDA to update the information. However, it is the responsibility of the owner or operator to ensure that it is meeting the registration and listing requirements of the FD&C Act. FDA is not required to update registration or listing information in response to such notifications.

The deadline for submitting comments is 4 August.

Draft guidance