Diagnostics Authority Falls ‘Squarely’ to FDA in Bipartisan Bill (2)

June 24, 2021, 3:32 PM; Updated: June 24, 2021, 6:25 PM

The FDA would regain some of its ability to oversee diagnostic tests developed in a single laboratory under a bipartisan measure introduced Thursday.

The bill, known as the VALID Act, aims to resolve an ongoing debate about the agency’s authority over lab-developed diagnostics, an uncertainty the Trump administration exacerbated last summer when it allowed more tests to hit the market without FDA review.

Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) reintroduced the measure, which stands for “verifying accurate leading-edge in vitro clinical test development.” It’s largely similar to the one the House members introduced last year just before ...

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