Lab Test Oversight Plan Scaled Back Under Revised FDA Proposal

Jan. 13, 2017, 10:03 PM

A compromise plan to scale back FDA regulation of laboratory-developed tests would focus on the riskiest tests while grandfathering any marketed tests from new oversight.

The Food and Drug Administration published Jan. 13 its Discussion Paper on Laboratory Developed Tests, exactly one week before the White House will change administrations and about two months after the agency said it would wait until President-elect Donald Trump takes office before finalizing any action on LDTs (44 PSLR 1261, 12/5/16, 224 HCDR, 11/21/16, 224 DER, 11/21/16, 27 MCR 1055, 12/2/16, 24 HCPR 1627, 12/5/16, 15 MRLR 690, 12/7/16, 10 LSLR, 11/25/16, 10 MELR, 11/23/16

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