New Regulatory Approach for Diagnostic Lab Tests Mulled in House

March 21, 2017, 4:07 PM

Lawmakers are mulling a new way for the FDA to regulate laboratory-developed tests under a bipartisan draft bill released March 21.

The draft Diagnostic Accuracy and Innovation Act (DAIA) from Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) would create a new category of regulated products called in vitro clinical tests (IVCTs). This product area would cover lab-developed tests (LDTs), as well as items like test kits, and would not be regulated as devices, drugs or biologics. Laboratory operations would stay under the authority of a different agency, the Centers for Medicare...

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