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  • 1.  devices put together in the hospital

    Posted 24-Apr-2018 14:23
    I have a few questions for anyone with experience with large medical equipment that is put together (installed) at the hospital or clinic.  The product I am asking about has a major component that is made by another manufacturer and is shipped separately to the hospital.  Therefore, the entire, completed large equipment cannot be "final acceptance" tested until it is installed.  It is not yet on the market, just investigational.  But in preparing for commercial, the company wants to ensure they are 21 CFR 820  compliant.

    • Would this installation and final acceptance be included in the Device History File (DHF?  I presume yes
    • If so, how do you have QA sign off and get official documents back to headquarters in a timely fashion (can you send electronically and get electronic response - if so, I presume one must ensure 21 CFR 11 compliance)?
    • Do you consider the necessary final acceptance testing should include installation qualification and operational qualification? 
    Thanks in advance,
    Deb

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    Debbie Koeneman
    United States
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  • 2.  RE: devices put together in the hospital

    Posted 25-Apr-2018 14:28
    Deb,

        There is plenty of QA expertise in this group and I hope someone with that background responds.   I have a background in radiology as a commercial lawyer, but without knowing what type of device you are talking about, I'm not sure if my comment will be relevant.

        First off, I wanted to make sure you are only talking about installation/acceptance after FDA clearance.   If you are planning to install an investigational device, I'm sure you know that part 812 is what needs to be followed.   I've worked on several matters where such devices were installed and used (and later upgraded to commercially-available systems to end their investigational status).

        Assuming you are talking about commercially-available devices, the sale agreement typically includes acceptance language and processes that are used for financial and regulatory purposes.   For example, if your device is in radiology, FDA Form 2579 would be used to document installation, and the hospital's biomed org would typically certify that the device is accepted and ready for patient use.   That acceptance from the end user becomes part of the device history (and could also be the basis for revenue recognition by the seller, if that's what the sale agreement stated).

    If you are in the capital equipment space, I think you'll find that there are existing practices that can be followed to ensure compliance with final testing and assembly rules.

    Roger

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


  • 3.  RE: devices put together in the hospital

    Posted 25-Apr-2018 14:57
    A to your Q1: I guess you are referring to Design History File (DHF).  Yes including validation activity and documentation (validation records). 
    A to your Q2: If implemented electronically.  Please make sure your system is compliant with 21 CFR Part 11 (Part 11) as other predicate rules are subject to Part 11, to the extent applicable (e.g., 21 CFR 820).
    A to your Q3: Yes, IQ/OQ/PQ (or its equivalent documentation) should be documented as part of your DHF.

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    Dr. David Lim, Ph.D., RAC, ASQ-CQA
    REGULATORY DOCTOR
    http://www.RegulatoryDoctor.US
    http://www.GlobalComplianceSeminar.com
    Phone (Toll-Free): 1-(800) 321-8567
    E-mail: David@RegulatoryDoctor.US
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    Original Message


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