Bill to Restore FDA Diagnostic Oversight to Come Within Weeks

May 12, 2021, 9:44 PM

Lawmakers plan to reintroduce a bill in the coming weeks that would restore some of the FDA’s ability to oversee lab-developed diagnostic tests, which the Trump administration stripped away last summer.

Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) are tweaking a measure they introduced last year known as the VALID Act, a House aide told Bloomberg Law. It’s unclear what the changes are, but the aide said they responded to feedback from stakeholders.

The legislation aims to resolve a longstanding dispute about whether and how the Food and Drug Administration can regulate diagnostic tests that are designed, manufactured, ...

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