Stacy Amin and Bethany Hills, co-chairs of our FDA Regulatory + Compliance practice, 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.
“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.”
Read the full article here. Refer to our client alert and recorded discussion, HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests.