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  • 1.  510K - Guidance for ownership transfer

    Posted 23-Mar-2022 11:46
    Good day-

    I am looking for guidance on how to transfer ownership of a 510K to another company.  I could not find any on the FDA website.  Anyone complete the process and have any guidance to share?

    Thanks.

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    Patty Beja
    Manager, Regulatory Affairs
    Port Washington NY
    United States[
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  • 2.  RE: 510K - Guidance for ownership transfer

    Posted 23-Mar-2022 12:46
    Hi Patty,

    Slide 66 of this presentation from 2015 is on transfer of 510(k) ownership - https://www.fda.gov/media/94060/download

    The crux of it is that the FDA does not track 510(k) ownership as is, but expects the companies involved to update registration and listing.

    In addition, I believe two companies can't manufacture under the same 510(k) number, so the new company should probably get an agreement from the selling company to stop manufacturing the device.

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    Akshay Kulkarni
    Fremont CA
    United States
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    Original Message


  • 3.  RE: 510K - Guidance for ownership transfer

    This message was posted by a user wishing to remain anonymous
    Posted 24-Mar-2022 11:13
    This message was posted by a user wishing to remain anonymous

    In the past, in addition to the clear requirement for the new owner of the 510(k) to create and maintain appropriate device listings for the clearance, I have sent an "add-to-file" letter to the DCC regarding the change of ownership.
    Original Message


  • 4.  RE: 510K - Guidance for ownership transfer

    Posted 23-Mar-2022 12:55
    Hi Patty,

    This was covered in the last section of this article: https://www.donawa.com/wp-content/uploads/2019/06/Who-owns-the510k.pdf.

    Also, this thread may be helpful:
    https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MessageKey=849635f4-c815-4dd1-854a-e3e3db18a708&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bm849635f4-c815-4dd1-854a-e3e3db18a708

    You can submit a letter to CDRH to show transfer of ownership, but it is not required. Ensure you have a contract or other documents proving the transfer, and a coordinate plan for listing the device under your company's ERDL once the former owner de-lists.

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    Ian Broome, M.S., RAC
    Needham, MA
    United States
    ***Any posts or activity shared on RAPS Forums are my own personal views; I do not speak on behalf of Boston Scientific Corporation (BSC).***
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    Original Message


  • 5.  RE: 510K - Guidance for ownership transfer

    Posted 24-Mar-2022 02:31
    Hello Patty,

    The previous posts are correct, there is no requirement to notify FDA when a company buys another company or even sells the 510(k) outright.  Typically a letter is sent to FDA informing of the change more as a helpful information and also be able to document internally.  As the 510(k) database is "done in stone" it does not change or reflect any current ownership of 510(k)s.  What is important is the Medical Device Listing clearly reflects the current product name (trade name), who is responsible (manufacturer), and this provides the linkage to the 510(k) number.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 6.  RE: 510K - Guidance for ownership transfer

    Posted 25-Mar-2022 08:05
    Team-

    It is much as i suspected.  I appreciate your confirmation. I will confirm contracts are in place, generate a letter to file, and inactivate the device listing numbers associated with the products.

    Thank you all for your input.

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    Patty Beja
    Manager, Regulatory Affairs
    Port Washington NY
    United States[
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    Original Message


  • 7.  RE: 510K - Guidance for ownership transfer

    Posted 25-Mar-2022 08:14
    As a few have identified there is no formal process but the suggestion of the letter notification is a valuable one but remember, with the annual site registration and devlce listing update, you will capture the transfer there.    In my past, I always had the letter signed by the sending and the receiving regulatory lead for the company with the letter being on the sending company's letter head.  We then maintained a copy in both QMS records folders.    The follow up was then the annual registration/listing.   More than once the FDA a few years later might follow up or ask as a part of their own monitoring and the letters helped to document the actual time the transfer occurred rather than just the annual registration timing.

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    Elisabeth George
    Head of Global Regulations & Standards
    Ft Lauderdale FL
    United States
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    Original Message


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