Attorneys See Questions in LDT Policy Change

Three Hyman, Phelps & McNamara attorneys say an 11/15 HHS announcement withdrawing the Trump administration’s policy preventing FDA from requiring premarket review of laboratory-developed tests (LDTs) without notice and comment rulemaking raises many questions. Writing in their firm’s FDA Law Blog, the attorneys say the “announcement is light on details, simply stating that the policy was withdrawn and that HHS no longer has a policy on LDTs that is separate from FDA’s longstanding approach in this area.”

The post notes that the firm has been critical of the longstanding FDA approach. The attorneys address questions involving laboratories performing Covid-19 LDTs, how the withdrawal of the notification pathway affects Covid-19 tests, and the effect of the change on non-Covid LDTs, and say there remains much that is unknown and could raise concerns for laboratories.