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  • 1.  Predicate - 510(k) device no longer listed by manufacturer?

    Posted 07-Jul-2020 18:46
    Edited by Julie Omohundro 08-Jul-2020 02:44
    Company is considering a predicate device that has been the subject of several 510(k)s over time, due to changes in intended use, technology, materials.  The client would like to use the original device as a predicate, but that device is no longer listed by the manufacturer.

    I've never dealt with this situation, but have heard it discussed a number of times.  Wish I'd paid more attention, LOL.  My understanding is that any device that has been cleared via the 510(k) process can serve as a predicate.

    If the 510(k) is in FDA's 510(k) database, does that mean that the device can be used as a predicate, even though it is no longer listed by its manufacturer in FDA's registration & listing database?

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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
    ------------------------------


  • 2.  RE: Predicate - 510(k) device no longer listed by manufacturer?

    Posted 07-Jul-2020 19:35
    Yes, if the device is no longer sold for business purposes, it can still serve as a predicate. However, if the device is very old, you may want to consider using a more recent product due to the FDA's hazy rule about predicates being within the last 10 years.

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    Isabella Schmitt, RAC
    Regulatory Affairs Consultant
    Houston TX
    United States
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    Original Message


  • 3.  RE: Predicate - 510(k) device no longer listed by manufacturer?

    Posted 08-Jul-2020 03:16
    Hi Julie,

    If it is contained in the FDA's 510(k) database it can be used as a predicate.  Though as Isabelle rightly says, anything over 5 - 10 years old, the FDA questions greatly.  In fact, on a couple occasions over the years, the reviewer asked about marketing material for both our device and the subject device.  This was in the context of substantial equivalence and claims/performance being made for both devices.  The device type has to basically be unchanged over the years in intended use, operation, technology, function, etc., to use a predicate device quite old.  Kind of opposite of your situation, I had to have "discussions" with the FDA reviewer because we were claiming substantial equivalence to a currently marketed device, i.e. current technology, current materials, that even though the predicate device 510(k) was only about 5 years, it did not resemble anything like their original 510(k) submission.  Those were fun discussions haha.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Predicate - 510(k) device no longer listed by manufacturer?

    Posted 08-Jul-2020 07:42
    Yeah Isabella 

    But that hazy policy  is not the law.  Unless you are choosing a device way way back, the 10 year cutoff is arbitrary and burdensome.  Forces people into spendy De Novos when there is no legal requirement  to do so.

    Just my opinion. That said, i wouldn't  use  a predicate from the 80s or early  90s, but most devices in the past 15-20 years had more data submitted to FDA.... 

    The predicate is supposed to currently marketed.

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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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    Original Message


  • 5.  RE: Predicate - 510(k) device no longer listed by manufacturer?

    Posted 08-Jul-2020 11:37
    Edited by Julie Omohundro 08-Jul-2020 12:11
    Thanks, Isabella, Richard, Ginger.  I guess I paid closer attention than I realized. :)  This is what I was thinking, but I appreciate confirmation from colleagues who have dealt with FDA on this.  The predicate in question is not quite 10 years old, so we'll see.

    Would also be interested to know...

    Has anyone had FDA raise the issue of an older predicate in the last year or so?   I thought its proposal to publish a list of older predicates got stomped on pretty well, not just in terms of a widespread lack of enthusiasm for the idea of a list, but some very compelling arguments in defense of older predicates. I remember thinking that, if purchasers of medical devices read through all the comments, they might be more inclined to favor devices that claimed SE to older predicates than to newer ones.   I have wondered if any of the comments might have led FDA to reconsider its attitude toward older predicates.

    Does anyone have any insights on where FDA is coming from on its apparent prejudice against older predicates?  Especially any insights that might be helpful in terms of addressing its concerns proactively in a 510(k)?


    ------------------------------
    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
    ------------------------------

    Original Message


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