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  • 1.  Interpretation of Section 862.9, Limitation to 510k Exemptions

    Posted 21-Dec-2023 09:25

    Hi....I'd like to confirm my interpretation of the FDA regulation in section 862.9, the Limitations of the 510k Exemption. Anyone care to weigh in?   It's at 21 CFR Part 862, Subpart A, Sec 852.9.    

    It begins:  

    "The exemption from the requirement of premarket notification . . . for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality".  (emphasis me)

    I'm reading this to mean that the exceptions itemized below this (items A-C(1-9)), only apply when the device (in my case an in vitro diagnostic device), has risks "associated w high morbidity or mortality,".  In other words, the exceptions don't stand on their own, but apply only under this high-risk scenario.

    At the end of the exceptions list, items C(8-9) appear to include all non-invasive and all near-patient in vitro testing, but it doesn't make sense to exclude ALL these, but only in the high-risk scenarios. That's how I read this. 

    Any feedback appreciated!



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    Kevin McLellan
    Owner
    Memphis TN
    United States
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  • 2.  RE: Interpretation of Section 862.9, Limitation to 510k Exemptions

    Posted 21-Dec-2023 10:32

    Hi Kevin

    So far it seems FDA still considers all point-of-care testing to be high enough risk to warrant premarket notification/approval. Maybe it's less likely that a test done in a lab would return wrong results leading to improper treatment? Even if the test itself seems innocuous, there doesn't seem to be any exception, apart from emergency use authorizations.

    https://www.fda.gov/files/medical%20devices/published/Procedures-for-Class-II-Device-Exemptions-from-Premarket-Notification--Guidance-for-Industry-and-CDRH-Staff-%28PDF-Version%29.pdf

    https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations

    https://ascls.org/point-of-care/

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-issued-emergency-use-authorizations-euas-related-coronavirus-disease



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Interpretation of Section 862.9, Limitation to 510k Exemptions

    Posted 22-Dec-2023 07:40
    Hello Kevin,

    I believe that your interpretation is flawed.  FDA states their reasoning in the first paragraph of Part 862, but it does not over-ride the specifics called out in subparts a , b, and c.  Signifcantly,
    Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:
    therefore, all of the subparts (a, b, and c) clarify and define the specifics.

    Regards,
    James



    Original Message


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