Home 5 Articles 5 Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)

Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)

by | Nov 24, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies

In a surprising reversal of policy that had already been reversed in recent months, the US Department of Health and Human Services (HHS) announced that the US Food and Drug Administration (FDA) will once more enforce premarket review requirements for Laboratory Developed Tests (LDTs). The Nov. 15 announcement comes just over a year after HHS removed FDA authority over LDTs in response to the COVID-19 public health emergency. FDA LDTs Regulation during the COVID-19 Crisis The COVID-19 public health emergency exposed the weaknesses in the FDA’s makeshift system of regulating LDTs via its legislative authority over new medical devices. The agency’s attempts to assert 510(k) premarket control over LDTs in the first days of the crisis at a time when innovative COVID-19 tests were in desperate need drew widespread criticism. FDA red tape was seen as hampering the effectiveness of pandemic response. FDA responded in March 2020 by unveiling a new policy empowering laboratories to develop and utilize their own tests, provided that they notify the agency that they were shipping products. In May, when it had become clear that the new policy had gone too far in the other direction by allowing for junk tests to reach the market, […]

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