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  • 1.  Modular PMA: Manufacturing, Design Controls and Quality System

    This message was posted by a user wishing to remain anonymous
    Posted 06-Jul-2022 09:15
    This message was posted by a user wishing to remain anonymous

    I have 10 years of Pharmaceutical quality experience and recently we acquired a medical device company and we are now in the Combinational Device Space and I am suppose to submit a Modular PMA. I have never done one. Our 2nd module is Manufacturing, Design Controls and Quality Systems. I would appreciate input from experienced medical device RA professionals on pointers on how to start compiling this submission and any FDA guidance's I should follow in order to start drafting this module. In addition, if you have any tips which I should follow as I compile this submission, that will really help me. 

    I am planning to draft it and depending on the need, might need an external consultant to review it. 


  • 2.  RE: Modular PMA: Manufacturing, Design Controls and Quality System

    Posted 06-Jul-2022 09:40

     

     

    Hi Anon,

     

    We at MED Institute have written a number of successful PMAs--mostly modular, and some combination products.  Have a look at the PMA review guidance...

     

    https://www.fda.gov/media/73513/download

     

    More specific guidance is in CDRH's guidance titled "Quality System Information for Certain Premarket Application Reviews"...

     

    https://www.fda.gov/media/71083/download

     

    If you would like more support, please feel free to reach out.  My contact information is below.

     

    Best regards,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     

     

     




    Original Message


  • 3.  RE: Modular PMA: Manufacturing, Design Controls and Quality System

    Posted 06-Jul-2022 12:27
    In addition to Ted's great reply and trustworthy services, I'll throw my hat in the ring too.  Here's what one of our clients said after our post-submission hiring and review of their PMA Manufacturing, Design Controls and Quality Systems section where shortly thereafter in a PMA hold letter the FDA's GMP reviewer uncannily echoed our review findings:

    "...After a few hours of sleep (and a lot less stress!), we wanted to send you a quick thank you note for all that you've done for [us] to‐date. Your contributions to our cause were above and beyond the call of duty, which we feel confident we're able to define accurately given our extensive experience with countless consultants. Your dedication is one thing, but your acumen when it comes to exactly what FDA is looking for is on a whole different playing field. Given that we're heading into Super Bowl weekend, I will leave you with this: like the great color‐man Tony Romo calls the plays before a quarterback executes it, you call the questions before FDA asks them. That foresight is the reason we are sitting pretty with a no‐483 pre‐approval inspection..."




    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


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