New Bill Would Change FDA Review Path for IVDs, LDTs

A new bill is in the works that would create a separate FDA regulatory pathway for in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs). Sen. Orrin Hatch (R-Utah) is expected to release a draft of the bill in the near future, Alan Mertz, president of the American Clinical Laboratory Association (ALCA), said. ACLA has played an active role in forming the content of the bill, meeting with Hatch several times this year to discuss the legislation. “Much like the 1976 Congress realizing devices didn’t fit the drugs pathway, we needed a new process for diagnostics,” Mertz said, referring to the Medical Device Amendments Act of 1976.
Devices & Diagnostics Letter