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  • 1.  Request for Predicate Devices

    Posted 16-Sep-2020 12:07
    We received a request for the predicate 510(k) numbers and device names used in several of our 510(k) submissions to the FDA.  We chose to use the 510(k) Statement vs. the 510(k) Summary in our submissions, so I believe this is why we are receiving the request.   Has anyone ever encountered this type of request, and if so, how did you handle the request?

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    Vicki Gail
    RA Manager
    California
    United States
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  • 2.  RE: Request for Predicate Devices

    Posted 17-Sep-2020 04:39
    Hello Vicki,

    Based on your information, I am assuming you mean your original 510(k) submissions were provided with a 510(k) Statement instead of providing a 510(k) Summary.  Then you are correct in understanding why you received this request.  This is the commitment your organisation makes when using a 510(k) Statement instead of a 510(k) Summary; which you need to respond within a timely manner, I think it is 30 days with the requested information.  Actually quite lucky they are only requesting the limited information, often times they just request the 510(k) file - meaning you need to provide everything, redacted as usual, which was originally submitted.  Make sure you provide only what is required, redacting any priority information, and provide within the timeframe requested by FDA.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Request for Predicate Devices

    This message was posted by a user wishing to remain anonymous
    Posted 17-Sep-2020 08:54
    This message was posted by a user wishing to remain anonymous

    Vicki,

    You signed the statement during the 510(k) submission. https://www.fda.gov/medical-devices/premarket-notification-510k/premarket-notification-510k-statement

    I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent) of (company name), I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
    Original Message


  • 4.  RE: Request for Predicate Devices

    Posted 17-Sep-2020 12:24
    Edited by Fred Varela, MRA RAC 17-Sep-2020 12:35

    Hi Vicki,

    You are correct. In essence, you're receiving a FOIA Request for cleared 510(k) submissions that opted NOT to provide a public 510(k) Summary during submission review and clearance.

    FDA requires 510(k) owners to provide safety and effectiveness (S&E) information supporting the FDA finding of substantial equivalence within 30 days of a written request. I've handled these FOIA requests by redacting information throughout the S&E sections of cleared submissions in order to blank out any privileged and confidential information that could be considered patient identifiers, trade secrets and commercial/financial information.

    It's a tedious, time-consuming exercise to be vetted by various stakeholders though.     IMO, it's always best to submit a well-crafted, 510(k) Summary at the time of submission.  Good luck!

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    Fred Varela, MRA RAC
    Regulatory Affairs Manager
    Philadelphia, PA
    United States
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    Original Message


  • 5.  RE: Request for Predicate Devices

    Posted 19-Sep-2020 03:29
    I think it is often one of those pay me now or pay me later situations.  In the rush to get the 510(k) submitted, so much easier and quicker to sign the statement than to prepare a well-crafted summary to include in the submission.  But then the company is stuck with responding to requests forever and ever amen. 

    Plus I don't see how a well-crafted summary isn't likely to facilitate review, hopefully reduce review time a bit, and also potentially avoid delays and deficiencies that are more a result of FDA not being able to find something (or figure out why you included it) than anything actually being missing from the submission.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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    Original Message


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