Article

What New FDA Policy Means for COVID Tests and Beyond

Law360

17 Dec 2021

Stacy Amin and Bethany Hills authored an article for Law360 discussing the U.S. Department of Health and Human Services (HHS) withdrawing a controversial Trump administration policy that prohibited the U.S. Food and Drug Administration (FDA) from requiring premarket review of laboratory-developed tests (LDTs), addressing the most common questions about the new policy, and making predictions for 2022 and beyond.

“Though the FDA has a long history of mostly not enforcing the premarket review requirements for LDTs, the agency has on occasion taken compliance action against certain tests, and has proposed and then pulled back on plans to more actively regulating LDTs,” the authors wrote.

They added: “In the case of a public health emergency, the FDA had taken the position even before COVID-19 that premarket review was required to ensure that tests’ design, validation, and performance were appropriate for an infectious disease, where inaccurate results could exacerbate the spread of the disease.”

“This enforcement approach by the FDA has widely been referred to as shifting sands, where the industry is not quite sure when the FDA might take a compliance action or when its policy of enforcement discretion might change. So the recent announcement by HHS has led to a host of questions about what going back to the past might mean for the future.”

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