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  • 1.  FDA medical devices audit

    Posted 19-Mar-2018 00:54

    Hi ,

     

    During the FDA audit, do the auditors check if we have the copies of the 510(k) submissions . Some of the submissions were done 20 years ago..

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

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  • 2.  RE: FDA medical devices audit

    Posted 20-Mar-2018 02:13
    Not usually, in my experience of 30+ inspections never had one ask to see the actual 510(k) submission.  However, design control information even for 20 year old products they did ask to see, so while you may not have the submission - if applicable - make sure you have design documentation.  510(k) submissions from 20 years ago are nothing like they are today, so generally not helpful anyway - I still remember a submission I did in 1994 that was like 8 pages !  Compared to today, the same type of product the submission would be over 100 pages.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: FDA medical devices audit

    Posted 21-Mar-2018 11:11
    My experience is similar to Richards. However, I recently did a mock FDA inspection using a former FDA inspector. She did ask for a copy of the 510(k) and reviewed current specifications against what was in the 510(k). So, looking at the 510(k) is atypical but not unprecedented.

    Hope this helps.

    Sent from my iPhone


    Original Message


  • 4.  RE: FDA medical devices audit

    Posted 21-Mar-2018 10:37
    Rashmi,

    I second what Richard states. In a recent FDA inspection covering a product that had very little modification since its original clearance in ~2004, the only records we pulled from the original premarket notification were design documents that we could not otherwise locate or that we felt were best reported in the 510k submission. For this, we only pulled and shared the relevant submission sections and explained from where we retrieved the record. The inspector did not ask to see the submission in its entirety, he/she only cared about the content in question.

    I hope this helps, and good luck!

    ------------------------------
    Christie Hughes
    Founder and Principal Consultant
    Integrys Consulting
    Austin, TX
    United States
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    Original Message


  • 5.  RE: FDA medical devices audit

    Posted 21-Mar-2018 20:29
    I don't think the QSIT has changed much since 1999 (https://www.fda.gov/downloads/iceci/inspections/ucm142981.pdf) and examining a 510(k) isn't on the inspectors "to do" list, as they are more likely to ask about complaint handling and CAPA systems.   

    The only 510(k) submission issue I would look out for are instances where the company is selling something now that they didn't think required a new 510(k), but, during an audit, the FDA says your analysis was mistaken and a submission is needed (e.g., updating a drug library on an infusion pump).    This might happen when they review complaints and cannot seem to find a corresponding correct product name.

    If you have a "letter to file" documenting why no 510(k) was needed, that would be worth reviewing in advance of an audit.


    Roger

    ------------------------------
    Roger Cepeda, JD, MBA, RAC
    MedTech Law LLC
    roger@medtech.law
    Mobile: 847-421-8361
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    Original Message


  • 6.  RE: FDA medical devices audit

    Posted 22-Mar-2018 09:39
    Hi Rashmi,

    This may depend on whether this is a routine audit or a directed audit (for cause). In a directed audit, if the submissions were relevant to the issue that FDA is seeking to address (e.g. have changes been made to the device without submission of a 510k), they may be more interested in the submission history. They should be doing this in collaboration with ODE, however, and you are well within your rights to ask that the premarket review branch be involved in any submission-related discussions during the inspection.

    It's worth trying to ascertain if this is a routine or for cause audit, I would never hesitate to ask this question directly when notified of an upcoming inspection.

    Good luck,

    Sean

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    Sean Bundy RAC
    Vice President Regulatory and Quality
    Aurora CO
    United States
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    Original Message


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