FDA Watch: New LDT Proposal Is Much Different from One Negotiated with Industry

摘要

The lab industry played an active role in the drafting of the Diagnostic Accuracy and Innovation Act (DAIA), a bill designed to establish a new regulatory regime for laboratory developed tests (LDTs). But last month, without consulting anybody, the FDA sent a Technical Assistance document (TA) proposing a DAIA re-write in the interest of "public health."