FDA clarifies 510(k) clearance transfer rules in new Q&A guidance

FDA this week published the draft guidance entitled, “Transfer of a Premarket Notification (510(k)) Clearance -- Questions and Answers,” which provides information in question-and-answer format on the transfer of ownership between 510(k) holders. An owner or operator of an establishment who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device intended for human use is generally required to register the establishment and submit listing information for all devices in commercial distribution.

Under section 510(k) of the federal Food, Drug, and Cosmetic Act (FDCA), each entity that is required to register their establishment must generally submit a 510(k) to FDA at least 90 days before proposing to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use, if the device is being introduced into commercial distribution for the first time. Additional notification requirements include the following:

• 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).
• When listing, if the device is not significantly changed or modified, the new 510(k) holder must supply the original FDA-assigned premarket submission number, unless submitting a new 510(k), in which case the new 510(k) holder would supply the new FDA-assigned premarket submission number.
• The new 510(k) holder must, if not previously entered into an operation described in 21 CFR 807.20(a), register within 30 days after entering into such an operation and submit device listing information, including the FDA-assigned submission number, at that time.

The new draft guidance clarifies that entities subject to 510(k) registration requirements include remanufacturers; reprocessors; specification developers; foreign manufacturers; domestic manufacturers introducing a device to the U.S. market; and finished device manufacturers that manufacture a device according to their own specifications and market it in the U.S., including accessories to finished devices that are ready to be used for any intended health-related purpose and packaged or labeled for commercial distribution for such health-related purpose. It further clarifies the following:

• There can be only one 510(k) holder for a device at a time. •Anyone who is required to list a cleared device – including contract manufacturers, contract sterilizers, repackagers, and relabelers – must use a 510(k) holder’s 510(k) number to list a device.
• When a 510(k) clearance for a specific device is sold or transferred from one person to another and the device is not significantly changed or modified in design, components, method of manufacture, or intended use, the new 510(k) holder does not need to submit a new 510(k), so long as the new 510(k) holder would not be proposing “to begin the introduction or delivery for introduction into interstate commerce for commercial distribution” of a device.
• FDA plans to utilize FURLS/DRLM to identify any person who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device in its postmarket surveillance efforts, including, for example, to timely notify a firm of the need to begin immediately a recall of a device that presents a risk of illness or injury.
• A previous 510(k) holder that ceases to perform an activity on or to the device that had previously been identified on the device listing (e.g., manufacturing the device) must update such device listing.
• An owner or operator who discontinues commercial distribution of a device must discontinue the device listing using FURLS/DRLM.
• Any entity that meets the definition of a “labeler” must meet Unique Device Identification (UDI) requirements, including, in general, having the UDI on the label of the device prior to commercial distribution. Labelers must also submit timely updates of certain information into GUDID.

Next steps

If an entity fails to register, list, update GUDID information, or submit a marketing application as required, their device might be considered adulterated and/or misbranded by FDA. The new draft guidance warns that “it is the responsibility of the owner or operator to ensure that it is meeting the registration and listing requirements” of the FDCA.

FDA has solicited comments on the guidance through August 4, 2025. If you have any questions on 510(k) premarket notification requirements, or may be interested in submitting a comment on the draft guidance, please contact either of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.

Authored by Randy Prebula and Jodi Scott.