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  • 1.  FDA 510K transfer

    This message was posted by a user wishing to remain anonymous
    Posted 08-Sep-2022 13:52
    This message was posted by a user wishing to remain anonymous

    Hello all, 

    We are the applicant and correspondent of a 510(k) application/clearance for a product. We were the distributor of the product. The original manufacturer of the product is company "A" and was cleared under them. Company "A" is no more and we have company "B" that would want to manufacture the 510(k) product and us selling it. 

    In this instance, what is the best approach?

    Any advice.


  • 2.  RE: FDA 510K transfer

    Posted 09-Sep-2022 05:57
    Hello Anon,

    There are a few other posts on Transfer of US FDA 510(k) which could provide other information.  A 510(k) submission is often thought of as an asset to a company which can be purchased/sold or transferred.  There was a guidance document drafted few years back but this was removed for some reason or another.  The US FDA does not involve themselves in this activities, but a 510(k) can be "transferred" from one company to another.  There is no formal process for this, usually a passive letter is sent to FDA notifying of this change to have on record more than anything for the two companies involved.  The 510(k) database does not change.  The new Company B needs to make sure the products sold and distributed are properly listed on the Medical Device Listing.  And depending on the circumstances, Company A should remove the products from their Medical Device Listing.

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


  • 3.  RE: FDA 510K transfer

    Posted 09-Sep-2022 07:23
    Hello Anon,

    Your question is somewhat contradictory in that you state that your firm is the applicant and correspondent of a 510(k) that was cleared under another company "A".  I fail to understand how if your firm was the applicant the 510(k) was cleared under another company.  However, if your firm is the 510(k) correspondent, you may have success in merely informing FDA that you are transferring the 510(k) from company "A" to your firm.  At that point, company "B" merely becomes a contract manufacturer, and provided the establishment medical device listing of both firms are updated appropriately, you should be able to proceed with marketing the device.

    Regards,
    James




    Original Message


  • 4.  RE: FDA 510K transfer

    This message was posted by a user wishing to remain anonymous
    Posted 09-Sep-2022 09:23
    This message was posted by a user wishing to remain anonymous

    From the text of your post, Company "A" seems clearly to be the owner of the 510(k). It has to be remembered that a 510(k) is an asset like any other. When you say Company A "is no more", I assume there must have been some dissolution of its assets. The question is, who has acquired the asset that is the 510(k)? A device can not be manufactured and/or marketed under a 510(k) by anyone who doesn't own the 510(k) [or who hasn't been granted formal authorization to do so by the owner of the 510(k)].
    Original Message


  • 5.  RE: FDA 510K transfer

    Posted 09-Sep-2022 10:28
    Edited by Mark Swanson 09-Sep-2022 10:29
    There are several missing pieces of information here that makes this a dangerous question to answer. Questions such as: Inside or outside the US, ownership of the device information (design history file), is there a current registration, what is the state of your quality system, etc. These need to be answered before simply transferring the 510k and taking on the role of manufacturer.

    I would recommend actually contacting the FDA and work through this or find a trusted advisor/consultant. Too often we don't just take the easiest/direct path because of the fear. I have found the best way is to simply ask. The first stop I can recommend at the FDA is the DICE (Division of Industry and Consumer Education) office. The contact information is here.

    If you know more and you have all the questions answered, there are instructions from the FDA on transfer of the ownership of devices and facilities here.

    Good luck!

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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States
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    Original Message


  • 6.  RE: FDA 510K transfer

    Posted 09-Sep-2022 18:44

    I suggest you assess the manufacturing processes and sterilization to ensure that the product is identical.  You may also have to conduct confirmatory testing, especially in regard to extractables and leachables, from the new product.  FDA will also need to be informed as this is considered a major change. 

     

    Regards,

    Gayle
    Gayle Freudinger
    Cardinal Health Regulatory Sciences
    gayle.freudinger@cardinalhealth.com

     



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    Gayle Freudinger
    Director, Regulatory Sciences
    Dublin OH
    United States
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    Original Message


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