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  • 1.  510(K) cleared device - transfer

    This message was posted by a user wishing to remain anonymous
    Posted 29-Aug-2022 17:34
    This message was posted by a user wishing to remain anonymous

    Hello Team, 

    Does 510K clearance expire (not the expiration of the device/kits itself) if no changes were made?

    Also, what is the policy on "transfer of owner" what can be done to 510k cleared device in that case? I believe there was a guidance "Transfer of owner....," which was withdrawn back in 2020.

    Can a 510K device be transferred from one company to another? If yes, what is the requirement?

    Thank you in advance.


  • 2.  RE: 510(K) cleared device - transfer

    Posted 30-Aug-2022 04:19
    Hello Anon,

    No, 510(k) clearances do not expire.

    There indeed was a guidance, but it "disappeared" not sure why or reasons behind.  To "transfer" a 510(k) this is usually done with a notification to US FDA that 510(k) K189999 has been transferred from Company A to Company B.  Note, this does not change anything on the FDA's 510(k) database as the original manufacturer, 510(k) Summary, and other information remains the same.  If the new company is going to sell product make sure the Medical Device Listing is updated accordingly.

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


  • 3.  RE: 510(K) cleared device - transfer

    Posted 30-Aug-2022 09:59
    1) No, a 510(k) clearance does not "expire" - as long as the device remains unchanged, the 510(k) is valid unless officially withdrawn, banned by FDA etc.

    2) 510(k)s are transferred among companies all the time and have been for years. Generally, if there is no guidance, an "add to file" letter to FDA from the 510(k) holder that states that the device/510k ownership is being transferred and gives the relevant details on the new owned (including establishment registration number if they have them etc) is all that is needed. It isn't a bad idea for the new owner to follow up in some way, but it isn't technically required.

    Ginger

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 4.  RE: 510(K) cleared device - transfer

    This message was posted by a user wishing to remain anonymous
    Posted 30-Aug-2022 13:58
    This message was posted by a user wishing to remain anonymous

    On a related note, after such a transfer there will still be devices in the field (and in finished goods inventory) still labeled with the old owner's information (address/phone number).  In cases where the old owner no longer exists and there is therefore increased risk of complaints going to the wrong place (or nowhere), does anybody have recommendations on best practices regarding how to handle such a situation?  

    Surely, phone forwarding is an immediate first step.  Overlabeling of commercial inventory at customer locations (eg, correction) or customer notification letter could also be performed, but feels onerous, depending on the extent of inventory at risk.
    Original Message


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