Regulatory Open Forum

 View Only

  • 1.  Device master files (MAFs) & review process

    Posted 25-Jan-2022 17:02
    Hi,

    Has anyone had recent experience with submitting a MAF? The guidance (Master Files | FDA) is pretty brief and doesn't saying anything about what to expect from review timescales or additional information request deadlines.

    Thanks

    ------------------------------
    Helen
    Victoria
    Canada
    ------------------------------


  • 2.  RE: Device master files (MAFs) & review process

    Posted 25-Jan-2022 17:12

     

     

     

    Hi Helen,

     

    Realize that MAF contents only get reviewed if they are referenced by a third party authorized to do so.  As such, the review timelines will be associated with the submission type the contents were referenced for.

     

    Further, the review comments typically go back to the third party, and they will need to circle back with the MAF holder to support responding--usually by adding information to the MAF.

     

    Hope that helps!

     

    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: Device master files (MAFs) & review process

    Posted 26-Jan-2022 03:41
    Hello Helen,

    I agree with Ted there is not a "review process" which occurs when submitting a Device Master File (MAF) to the US FDA.  The ones I have submitted recently did not receive any kind of feedback or requests from the FDA after long period of time.  Of course, I can assume everything in the file was magnificent and no questions haha.  But in reality is what Ted mentions this is submitted by a company because the technical information concerning the device, component, or materials are being referenced by another application made by another company.  Back in some early ones when FDA did ask questions sometimes they went to the submitter company (where we then needed to update our MAF) or they contacted us directly because there was not sufficient detail or a testing report was not provided.  As the information is kept confidential (the whole idea around an MAF) providing sufficient detail will prevent questions in the future.  There are no timescales or deadlines for a response; delays in response may just hinder the third-party company getting the submission through timely.

    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: Device master files (MAFs) & review process

    Posted 26-Jan-2022 07:46
    Edited by Karl Nittinger 26-Jan-2022 10:32
    I have had extensive experience with Device Master Files in the recent past. There is no review and approval by FDA of a device master file itself. Therefore, there is no relevant review and approval timeline. Device master files are simply repositories of technical information that FDA can access by authorization from the master file owner to facilitate their review of a premarket submission (typically - but not necessarily - a premarket submission submitted by a 3rd party).

    The only feedback that will be received from FDA after submission of the master file is acknowledgement of receipt which includes the master file number that has been assigned to it by FDA. I have submitted device master files to FDA and received the receipt acknowledgement including the MAF number on the very next day. The MAF number can be utilized as needed immediately upon receipt.  


    ------------------------------
    Karl Nittinger


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

    Original Message


Related Content