FDA Floats Lab Test Oversight Bill Revisions; Device Makers, Clinical Labs Praise Proposal

August 09, 2018
Following years of debate on the issue, FDA is floating legislative language that would cement the agency's authority to regulate high-risk clinical laboratory diagnostics -- including laboratory-developed tests and in-vitro diagnostics –- under a risk-based framework in which lower-risk tests could go through FDA's new, voluntary precertification pathway. The plan drew praise from device test manufacturers, clinical labs and patient advocates, who had been divided on what path FDA should take to regulate clinical lab tests that historically fell in...

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