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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