Regulatory Open Forum

 View Only

  • 1.  Third Party Review Organization - Regulatory Technology Services (RTS)

    Posted 29-Mar-2021 04:56
    Hi
    I am interested in hearing if anyone has had experience using Third Party Review Organizations such as RTS for 510k clearances of Physical Medicine devices.
    I thought the only option was submit to FDA but I'm told that there are now also third parties accredited by the FDA for review of 510(k)s. So it is possible to get clearance for less-complex devices using accredited third parties instead of FDA.
    Im interested to hear from anyone with knowledge of this.

    regards



    ------------------------------
    Mike Kilkelly
    Quality & Regulatory Affairs Manager
    Galway
    Ireland
    ------------------------------


  • 2.  RE: Third Party Review Organization - Regulatory Technology Services (RTS)

    Posted 30-Mar-2021 08:21
    Hi Mike

    I have used RTS many times and also TUV SUD and Intertek as 3rd party reviewers.  There are Pros and Cons in that you can get stuck with less chances for appeal if your "reviewer " at the 3rd party is less than reasonable or not an expert in one area of the 20 in the 510k.  Once submitted with a full hyperlinked RTA checklist and hyperlinked  Table of contents and still had the 3P reviewer saying there was no sectiojn on certain things.   And my response was " please look at Section X , shown in the TOC". Frustrating they don't bother to read sometimes.

    Email privately if you would  like.  Overall I liked it, but I don't think that for devices in evolving areas you will get the most bang for your buck anymore.  I have had everything from an 18-day onsite real-time clearance to 7- 8 months with argumentative 3P reviewer who boasted I had no appeal opportunity.  (Wrong, and ultimately not needed). And things in-between from  34 days with another reviewer at the same 3P for adding a new indication to 47 days total time for a new 510k.


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

    Original Message


  • 3.  RE: Third Party Review Organization - Regulatory Technology Services (RTS)

    This message was posted by a user wishing to remain anonymous
    Posted 30-Mar-2021 16:58
    This message was posted by a user wishing to remain anonymous

    Hello Mike.

    I do think that third party reviews get through FDA faster and rarely receive NSE's.

    But for a complex device, I'd steer clear.  As a former reviewer, I saw things cleared via the third party program that caused a lot of future postmarket and compliance problems, because the third party wasn't aware of all the hot-button issues in my device area.

    Third party review organizations do not have the internal expertise that FDA has.  They do not typically have access to physicians, to previous internal FDA review memos, or engineers or scientists who are experts in the particular device.  Without those resources it is difficult to do a meaningful review of a complex device.  The third party review memos I saw at FDA, even from reputable organizations, were sufficiently bad that we were instructed by management to disregard them and start our reviews from scratch.  Of course this was frustrating, as the deadlines were shorter.


    Original Message


Related Content