Header: Decibio has released a 15-page white paper that assumes the FDA LDT regulation will go forward, more or less just as proposed, and then taking a wide view of the strategic implications.
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The FDA's proposal to regulate LDTs, rolling out reviews or test withdrawals within a few years, has triggered many responses. Some organizations are strongly supportive, others are strongly opposed (for the downsides, see exhibits like the ACLA comment letter and the Hyman Phelps comment letter). For the FDA's plans (full steam ahead) see links and quotes from FDA, here.
The Decibio White Paper on FDA LDT
The consultancy Decibio has released an important 15-page white paper that takes a distinctive posture. The white paper assumes the FDA LDT regulation will proceed, more or less as proposed, and then takes an elaborate and wide-ranging view of what that means for stakeholder strategies.
Find it here:
https://data.decibio.com/regulatory-reckoning-ldt-white-paper
Worthwhile reading.
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I've mostly had a different entry point - that the costs and man-years of labor both at FDA and outside it make the plan unfeasable at anything like its current form/ Nobody has $50B to spend on a couple years on regulatory labor, nor does the labor even exist, if the money appeared.
Plus, tie-ups in court could last several years (see ACLA and Hyman Phelps earlier). Under the resulting mess, alternatives like VALID could resurface, not now, but in 4-5 years... By which time the US would also incorporate what would be several years of European experience with the LDT lessons from the imminent IVDR.
AI Corner.
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