Congress Revives Talks On LDTs With Clock Ticking On FDA Rule
While lawmakers continue to debate how LDTs should be regulated, the FDA’s proposed rule is fast approaching
During a recent hearing of the US House Energy and Commerce Health Subcommittee, lawmakers discussed the best approach to regulating laboratory developed tests (LDTs) with a panel of experts representing clinical labs. At issue was the FDA’s proposed rule that places LDTs under the same regulatory purview as other in vitro diagnostics, which would require medical facilities to receive agency approval for the LDTs they develop in their own labs.
