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LDT Regulation is Coming to a Head: Lab Directors Send Letter to OMB Urging Rejection of FDA Draft Guidance

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A letter was sent today to Brian Deese, Acting Director of OMB, by 23 lab directors urging him to withhold FDA’s draft guidance regarding LDT regulation. The bases for this resistance are fourfold:

1. LDTs are ubiquitous and vital to the practice of medicine;
2. LDTs are not medical devices, but rather medical services, and so are not under FDA jurisdiction;3. LDT providers are already highly regulated;
4. FDA regulation of LDTs would stifle innovation.

The spokesperson for the group is Edward Ashwood, MD, CEO or ARUP Laboratories, and among the signers are the heads of the clinical labs at most of the country’s largest medical universities.

Read the letter here.