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  • 1.  Regulatory Timeline - Medical Dec

    Posted 18-May-2017 13:35

    Hi All, 

    I am a grad student at Northeastern University currently pursuing my MS in Regulatory Affairs. I am working on a medical device project for a mock drug-device combination device (Class II) which is currently undergoing animal studies and whose target market launch date is March 2018. I require some guidance on how to frame my timeline for getting an IDE first and then moving on to an 510k. I am currently revising the available FDA guidances on this topic and I would highly appreciate any help about framing my strategy for the regulatory timeline of this device such that it gets on the market by March, 2018.

    Thank you.



    ------------------------------
    Sincerely,
    Pratik Pednekar,
    MS in Regulatory Affairs,
    Northeastern University,
    Boston, MA,
    United States
    prtkpednekar@outlook.com
    ------------------------------


  • 2.  RE: Regulatory Timeline - Medical Dec

    Posted 18-May-2017 15:09
    Well, there are a lot of unknowns that would need to be understood in order to create a good strategy, and I am not totally inclined to go too far in doing your class project, but I will toss out a few questions you should consider?

     - how long is the review cycle (both 510(k) and IDE cycles) likely to take? is there an easy to follow guidance for the product type? is the drug substance new in this space and likely to require a CDER co-review?

    - what are your clinical trial endpoints? how many patients do you need for statistical relevance? How often do your proposed sites see patients that fit the profile? with all this, how long will it take to enroll and follow your patients?

    - how long will your sites take to get up and running once your IDE is approved?

    - how long will it take to analyze and write up your data?

    - is your animal model well-understood?

    - has there been a pre-sub meeting or agreement so that FDA and company are totally aligned on the work to be done?

    There are more, but those will get you started....

    g-


    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
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    Original Message


  • 3.  RE: Regulatory Timeline - Medical Dec

    Posted 18-May-2017 21:54

    If you are planning to file a 510(k), then your device should have a predicate with a classification number and a product code. 

    I would look at the FDA's premarket notification database to find relatively recent decision letters and 510(k) summaries available for other devices with the same product code.  This is easy to do, because happily the database can be searched by product code.  Then you can look at the dates those 510(k)s were received and the dates on which they were cleared; these can help your estimate the time frames for your 510(k)

    If you feel the need for an IDE, then most likely those 510(k)s were also supported by clinical data, probably collected in trials very similar to the one you are planning to do.  These trials should be listed on clinicaltrials.gov, and the trial number is usually provided in the premarket notification database.  The date those studies were initiated and completed will be available on clinicaltrial.gov, and can provide you with an estimate of the time it will take to complete your study.

    As Ginger has noted, study start and completion dates are not the whole story on how long it takes to complete an clinical trial.  Much comes before, and much comes after.




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

    Original Message


  • 4.  RE: Regulatory Timeline - Medical Dec

    Posted 19-May-2017 03:10
    Pratik, I can't comment extensively right now because I do not have the time but we need more facts here about the combo.  With human clinical trials in the picture your timeline may be of a year or two or more.  An IDE does put FDA on a 30 day decisional clock, but they may drive this to a pre-sub which they set in a 75-90 day time frame ( we usually get them faster).  

    FDA likes to jump on the development team to help you design your trial.  And they will chew up your time between now and the end of the year for sure doing that. Then you actually have to file (or refile) your IDE and get approval; then execute the trial: report it out; do your 510(k) and file it with an RTA checklist review; and await an Additional Information letter to which you may take or need 6 months to respond. This all assumes FDA agrees with the 510(k) path.  A combo could end up as a  de novo.

    It will never happen by March 2018.

    Mark DuVal, J.D., FRAPS
    DuVal & Associates, P.A.





    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


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