Pharmaceutical & Life Sciences News

Lawmakers Ready to Unveil Bipartisan Diagnostic Test Bill

Feb. 6, 2020, 8:27 PM

Lawmakers are slated to introduce legislation this month that would change the way the FDA regulates medical screening tests, a House staffer said on Thursday.

The bill aims to resolve a lingering and sometimes contentious debate about whether and how the Food and Drug Administration should regulate laboratory-developed tests (LDTs), which are diagnostics made by a single laboratory. The legislation has bipartisan, bicameral support and is set to be introduced by the end of February, the staffer said.

The bill would give the agency new authority over diagnostics by creating a category of medical products called “in vitro clinical tests,”...

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