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  • 1.  CLIA Lab and FDA QS Requirements

    This message was posted by a user wishing to remain anonymous
    Posted 15-Sep-2020 09:40
    This message was posted by a user wishing to remain anonymous

    A company uses an outside lab to conduct analytical testing for an investigational IVD Under an IDE; the lab is Also CLIA certified for appropriate complexity.  They plan to treat The lab Like any other vendor under the QS.

    What, if any, device QS Regulation must that lab Comply with?  May the CLIA certification be used in lieu of compliance to 21cfr part 820?  Is the lab subject to fda inspection even though CLIA already inspects?



  • 2.  RE: CLIA Lab and FDA QS Requirements

    This message was posted by a user wishing to remain anonymous
    Posted 15-Sep-2020 13:39
    This message was posted by a user wishing to remain anonymous

    Hi,

    Although not likely unless the IVD is high risk and used for treatment decisions, the lab can be subject to an inspection by the FDA.  21 CFR parts 50, 54 and 56 are important for the conduct of clinical studies.  The sponsor company is responsible for making sure that the lab site is conducting the study according to the approved protocol and that the records are maintained and monitored appropriately.
    Original Message


  • 3.  RE: CLIA Lab and FDA QS Requirements

    Posted 16-Sep-2020 04:13
    Hello,

    As a vendor for conducting testing under a clinical study, the requirement for QMS should be specified by you as the Sponsor or running the study.  There are various regulations to be considered like mentioned GCP regs and also the GLP regs.  Another consideration you could make from a QMS perspective is the lab being certified to ISO 15189 which is a QMS structure for laboratories.  CLIA activities are QMS related, but also product related, so having a structure built around ISO 15189 or even ISO 9001 with emphasis on GLP would be ideal.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: CLIA Lab and FDA QS Requirements

    Posted 16-Sep-2020 09:37

    There may be more going on here than I encompass in my answer. If so, please provide additional information.

    First, you say this is an investigation device with an IDE. I infer this means Part 812 and not an RUO or IUO.

    You should treat the lab as any other vendor, meaning 820.50. You will establish the requirements, evaluate, selected, keep records, issue POs with purchasing data, etc.

    Because the lab is doing work under an IDE, they should implement FDA's GLP regulation. FDA can inspect them under the IDE rules.

    FDA does not regulate clinical labs, CMS does through CLIA. Typically, a clinical lab is not a device manufacturer, so Part 820 does not apply. (I'm ignoring the LDT and enforcement discretion issue.)



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


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