Industry asks for clarification, consistency in FDA’s 510(k) transfer guidance

Medtech industry stakeholders have asked the US Food and Drug Administration (FDA) to make significant changes and clarify its proposed guidance on what regulators expect from companies that acquire 510(k)s from other companies. They have asked that terms used in the guidance be consistent with their use across the agency and that responses be changed to ensure they are legally consistent.

In June, FDA published a draft questions and answers guidance that detailed the responsibilities of new owners of 510(k) clearances when products are sold or transferred to another entity. Since its publication, several stakeholders have written to the agency asking for changes to clarify regulatory requirements and ensure consistency. (RELATED: FDA issues guidance on transferring 510(k) ownership, Regulatory Focus 9 June 2025)

The Medical Device Manufacturers Association (MDMA) asked FDA to revise the title of the draft guidance to "Transfer of a Cleared Premarket Notification (510(k))" to clarify that the guidance is intended for 510(k) notifications that the agency has already cleared. Furthermore, it asked that the agency revise the definition of relabeler so that it is consistent with the definition of the word on its website, where it states a relabeler is someone who doesn't significantly change the labeling or otherwise affect any condition of the device from the original 510(k) holder.

"The definition of 510(k) holder in this guidance should be expanded to be clear that the person who holds the 510(k) includes the entity responsible to FDA during the 510(k) review and any later interactions thereafter, as well as one who has a device exempt from the 510(k) requirements under the FDCA, unless transferred," said MDMA.

The group also asked FDA to revise the definition of foreign manufacturer by including language stating that a finished device manufacturer is required to meet 510(k) requirements if it manufactures a device or its accessories based on its own specifications for the US market.

MDMA asked FDA to state that manufacturers who acquire a 510(k) may use it as a predicate in a Special 510(k) submission.

"Allowing this pathway, under appropriate circumstances, would enable meaningful device improvements while ensuring continued compliance with FDA’s regulatory requirements," said the group.

While the draft guidance states that there can only be one 510(k) holder, MDMA argues that several innovators may collaborate on designing a device and may want their own 510(k), in which case there may be multiple 510(k) holders for the same device. The group also asked FDA to clarify how it plans to handle disputes when multiple manufacturers lay claim to the 510(k) and proposed including a specific agency contact to address such dispute resolutions.

MDMA asked for clarification on issues such as when a 510(k) transfer triggers a need to update the device listing and the timing requirements for updating the listing. The group also raised concerns that FDA's unique device identifier (UDI) and labeling expectations do not consider finished products acquired by a new company but not distributed.

"As such, FDA it seems wishes to deem any failure to correct or update the labeling on all of these devices as 'adulterated and/or misbranded,'" said MDMA. "Presenting the expectation this way would likely result in significant device shortage during the sale and transfer of assets from one firm to another, especially for large entities.

"We recommend updating the guidance to allow flexibility for firms to proceed with a technology, business or IP transfer in an orderly and planned manner consistent with the transfer agreement and in a way which maintains patient access," the group added. "Alternatively, the FDA can remove the text stating that failing to update GUDID information might be considered adulterated and/or misbranded."

Similarly, it also asked the agency how companies should manage 510(k) submissions that are under review during a company transfer.

MDMA said the guidance doesn't state how companies should handle devices that were granted under the De Novo Pathway and published in the De Novo database, but after that the De Novo is transferred.

"The guidance does not explain if the same timeline expectations are expected for these De Novo devices," said MDMA. "We recommend that the transfer information be submitted to the FDA/CDRH Document Mail Center and the new De Novo holder register, and list just as described above.

"We note that the De Novo then becomes a potential predicate for future 510(k)s for the type device," the group added.

Medtech lobby group AdvaMed commented on the draft guidance and asked for specific changes. The guidance currently states that when a 510(k) clearance is sold or transferred from one company to another, the new 510(k) holder must list the device in the FDA Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM). AdvaMed asked the agency to clarify that the new listing number differs from that of the previous 510(k) holder's.

"The suggested approach would enable the Global Unique Device Identification Database (GUDID) record to be updated by incorporating the new listing number and removing the outdated one," said the group. "The previous 510(k) holder would deactivate the old listing number, and once deactivated, it must be removed from the GUDID record."

AdvaMed echoed MDMA's request to harmonize terms and definitions in the draft guidance with other FDA resources to ensure they are consistent.

"The 510(k) Premarket Notification Database (commonly known as '510k Database') is a publicly available resource used by a variety of stakeholders," the group added. "It is important to clarify that the 510(k) Database reflects information about the 510(k) submission at the time of the original clearance and does not change; the '510(k) Applicant' listed on the 510(k) Database may be different from the current 510(k) holder."

AdvaMed also asked FDA to revise question four on the need to submit a new 510(k) after obtaining a cleared 510(k) from another company. As currently written, the group says the answer implies that the need for a new 510(k) is contingent on whether the cleared device is already in commercial distribution. It said the misinterpretation could mean companies file redundant and unnecessary 510(k) submissions.

"Consider the scenario where a 510(k) clearance is sold shortly after FDA renders the decision and the device is not in commercial distribution at the time of transfer," said AdvaMed. "The original language in the draft guidance implies that the new 510(k) holder would be required to submit a new 510(k) submission for the identical device because they are “proposing to begin the introduction” of the device into interstate commerce for the first time."

The Consumer Healthcare Products Association (CHPA) also took issue with FDA's response to Question 4. It notes the guidance currently states that new 510(k) holder do not need to submit a new 510(k), if the new 510(k) holder do not plan "to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device.” The group says the latter part of the statement isn't consistent with current law and regulations. It asked FDA to delete the latter part of the statement.

AdvaMed also asked for clarification when new 510(k) owners must register their device in FURLS and DRLM. The group noted that transfer of assets from one company to another is multifaceted and complex, and allowing companies to register their devices 30 days after they have completed transfer of assets is a clearer timeframe. Similarly, the group asked for clearer requirements for companies to update their unique device identifier (UDI) labeling.

"The original language alone does not take into account common scenarios where there may be a lag in the update to the UDI on the device label, such as labeling on existing finished devices that are not yet distributed or devices being manufactured during the transition phase of a 510(k) transfer," said AdvaMed. "The suggested additional language is intended to clarify that the timing of the requirement to update the labeling is not rigidly tied to the date of transfer as such an interpretation could result in device shortages, particularly when there is a lengthy acquisition and transfer process.

"The suggested language is intended to help prevent possible device shortages and emphasize the purpose of the updated labeling," the group added.

AdvaMed asked FDA to clarify what post-market obligations new 510(k) holders have, especially regarding inherited adverse events, recalls, and complaints. It also asked the agency to clarify that a 510(k) submission may include bundled multiple devices per its previous guidance.

"The draft guidance does not discuss the scenario where the 510(k) holder opts to sell or transfer only certain device(s) (i.e., when the 510(k) holder retains the clearance of at least one of the devices cleared in the submission)," said AdvaMed. "We recommend the guidance discuss partial ownership or shared rights for a single 510(k) submission number and how these are to be handled in FURLS."

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Industry asks for clarification, consistency in FDA’s 510(k) transfer guidance

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