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  • 1.  Catch-up 510(k)

    Posted 22-May-2019 13:36
    Hello, 

    Does anyone have experience submitting a catch-up 510(k)? Submitting a letter to file?  Is there a guidance on this? 

    Karen

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    Karen Zhou
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  • 2.  RE: Catch-up 510(k)

    Posted 23-May-2019 09:44
    Karen,

    FDA requires 510(k)s to be filed when significant changes are made to the device.  What we call a "catch-up" 510(k) is really no different than any other 510(k).  The term usually means that there have been incremental changes over time that were not deemed to be significant in and of themselves at the time, but the design has "drifted" enough from the original 510(k) to be "significant".   Filing a new 510(k) will "catch up" the incremental changes to a new 510(k) that then becomes the baseline for subsequent changes.

    Make sense?

    Cheers,
    Melissa

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    Melissa Walker RAC
    President & CTO
    St Louis MO
    United States
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    Original Message


  • 3.  RE: Catch-up 510(k)

    Posted 23-May-2019 11:17
    Karen,

    I'm with Melissa on the catch-up 510k for cumulative changes that are indeed significant. I presume you are familiar with the following FDA guidance: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm
    If you were to do a comparison between the cleared device and the current version using the flowcharts, do you come up with something that may be deemed significantly different? Unless you are certain the changes are significant, I'd advise against it--a letter to file (LTF) should be sufficed. The LTF is an internal documentation, fancy wording for regulatory justification that design changes do not need a new regulatory submission. Kindly refer to the FDA's Deciding When to Submit a 510(k) for a Change to an Existing Device to help with your decision-making. 





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    Jo Huang RAC
    Tyler TX

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    Original Message


  • 4.  RE: Catch-up 510(k)

    Posted 23-May-2019 12:42

    Hi Karen, I have a friend who is a consultant and he could provide you some initial, complimentary direction on this. Feel free to email me and I'll connect you two.

     




    Original Message


  • 5.  RE: Catch-up 510(k)

    Posted 24-May-2019 07:45

    It is my experience that a "catch-up" 510(k) is done in two instances.  First, when a company needs has a submittable change to the device and the device has been incrementally modified numerous times before, then the previous changes (covered in letters to file) are also described, but clearly indicated as already having been implemented.   The other instance is when a company transfers, is sold or sells a device and the purchasing company determines that changes should have been submitted, then a catch-up is filed.

     

    Otherwise, I rarely see a company that will file a "catch-up" based on the planned implementation of a change that should be a "letter to file" on its own, regardless as to how many "letter to file" changes have been made before.

     

    If you file a "catch-up", it is important to be clear about the status of the changes that have already been implemented vs the change that the company feels should be filed.  You should never indicate that any of the changes should have been filed as this is an admission that the devices in the field are adulterated.

     

    There isn't any guidance on this.  I have done both before and would be glad to help.

     

    Lee Leichter

    President

    P/L Biomedical

    10882 Stonington Avenue

    Fort Myers, FL 33913 USA

    Office: +1-239-244-1448

    Cell: +1-239-994-6488

    Email: leichter@plbiomedical.com

     




    Original Message


  • 6.  RE: Catch-up 510(k)

    Posted 24-May-2019 08:42
    Hi Karen:
    I agree with the above assessments, but I would like to add that there used to be a practice in regulatory where firms would submit what is actually called an "add to file" for a 510(k). It was kind of treated like a post clearance amendment; however it was requested by FDA that firms stop sending these types of document in since there was no way of processing them. The FDA has no formal way of providing feedback to the firm. Therefore, this practice is not recommended. 

    Add to files are still used in rare cases. For instance during up classification (MOM hips & POP mesh) if a firm was to remove the class 3 product codes/ indications for use from their 510(k), FDA May request he firm provide the revised indications form & 510(k) summary via add to file to the cleared 510(k). 

    It it seems like a special or traditional 510(k) would be your best option. I'd be happy to discuss the strategy behind a 510(k) that has older, previously implemented, changes as there needs to be some consideration taken as to how to best document these changes. Reach out via private message or email and we can talk more!

    Best of Luck!

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    Andrea Pilon Artman, MS, CQE
    President & Principal Consultant
    SpectRA Compliance, LLC
    Frederick, MD
    USA
    andrea.artman@spectracompliancellc.com
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    Original Message


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