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  • 1.  PMA testing vendor redacting details

    Posted 03-Dec-2018 11:06
    I have a client working with a vendor to conduct welding testing, and the vendor is claiming that welding parameters are confidential and will be redacted within reports. In addition, they propose redacting specific details from the validation protocol and report, INCLUDING process parameters. They will only provide a test result.

    I have never run into this before - and I've been around a long time. This testing is for a PMA product which will likely be a panel track submission.

    Has anyone successfully shepherded a PMA submission through FDA with this scenario? I'm wondering if we'd have to have the vendor provide these details directly to FDA.

    Thanks in advance,
    Karen

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    Karen Bannick MA, FRAPS, RAC
    Principal & Founder
    Bannick Consulting Alliance
    karen@bannickconsulting.com
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  • 2.  RE: PMA testing vendor redacting details

    This message was posted by a user wishing to remain anonymous
    Posted 03-Dec-2018 12:36
    This message was posted by a user wishing to remain anonymous

    In the drug development, we ask the vendors to provide confidential information via DMF to the FDA. You probably have equivalent in the device field?
    Original Message


  • 3.  RE: PMA testing vendor redacting details

    Posted 04-Dec-2018 01:26
    Karen,

    Yes, I have dealt with that before and as the follow-on poster said: submission of a Device Master File (MAF) would be essential.  During a PMA review, the Agency does want to see that level of detail so if a third party is not going to provide that information due to confidentiality or proprietary processes, this can be challenging.  Using the MAF process allows your supplier to submit information to FDA that will be held confidential.  In fact, the MAF process is "under" the PMA submission part Master Files that explains would should be included.  This is free, but FDA expects good content not just a couple product specification sheets.  The challenge we had was then to get our vendors to submit a MAF for the component so we could reference in our PMA.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: PMA testing vendor redacting details

    Posted 04-Dec-2018 01:25

    Hi
    in this case in EU , the all documentation incl. records about validation have to be send by  manufacturer to Notify Body who is responsible for doing conformity assessment acc .to MDD 93/42/EEC for evaluation.
    BR
    Evangelos



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    Evangelos Tavandzis
    Praha
    Czech Republic
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    Original Message


  • 5.  RE: PMA testing vendor redacting details

    Posted 04-Dec-2018 08:14
    Hi Karen

    Will they file a DMF your client can refer to? I would suggest your client ask for that and you discuss it with the FDA.

    I had a silicone supplier for an implantable in the 90s that would not disclose key information,  and we had to just refer to their DMF with a letter of access included in the IDE, etc.

    It is a common mechanism in drug filings and I have prepared both drug filings and DMFs, but that was the first time I had seen it used for device manufacturing processes and component information.

    Good luck!


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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


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