ACLA Letter to Congress re FDA Power Grab

Furthermore, the FDA TA inappropriately suggests that FDA currently has authority to regulate LDTs as devices. The TA states, for example, that FDA “retains” jurisdiction over LDTs. ACLA has repeatedly asserted, and continues to assert now, that laboratory developed tests are not devices, and therefore FDA has no authority with respect to LDTs under current law that would be “retained” under any new framework.