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  • 1.  FDA Proposed LDT Rule

    Posted 11-19-2023 09:16

    Hello West Virginia Chapter members,

    I wanted to get your take on the proposed FDA rule to increase oversight of Lab Developed Tests (LDT's).  Below are links to the proposal slide deck and rule itself. 

    FDA LDT Slide Deck

    FDA LDT Proposal


    I personally think it's taking too broad of a bureaucratic approach to something that could be more specific. It could also curtail test innovation and availability. I understand the need to have more oversight over it, but perhaps more CLIA oversight of the labs rather than FDA would be better?  Or perhaps that will be the end result

    Let me know what you think and if we would like to put together a comment on this rule.

    Thank you!



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    Jonathan Perry, MLS(ASCP)
    President
    ASCP West Virginia Chapter
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  • 2.  RE: FDA Proposed LDT Rule

    Posted 05-03-2024 21:04
    Edited by Jonathan Perry 05-03-2024 21:04

    MAJOR UPDATE:

    The FDA has finalized the rule for Lab Developed Testing. Please join their webinar on May 14 at 1pm. I'm sure we'll all be following up on it more in the coming months and years. 

    https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024



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    Jonathan Perry, MLS(ASCP)
    President
    ASCP West Virginia Chapter
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    Original Message