LDT Rule Must Be Finalized By May To Avoid Congressional Scrutiny

Republican critics of FDA’s controversial rule seeking to assert regulatory authority over laboratory developed tests potentially could try to block it through the Congressional Review Act (CRA), and lawyers say that FDA might have to finalize the rule as early as May 2024 to avoid a lookback period for so-called “midnight rules” under the CRA. Under the "midnight rules" provision of the CRA, Congress can consider a joint resolution to disapprove multiple regulations submitted for congressional review during the last...