Home » LAWMAKERS INTRODUCE BILL TO STRENGTHEN OVERSIGHT OF LABORATORY-DEVELOPED TESTS
LAWMAKERS INTRODUCE BILL TO STRENGTHEN OVERSIGHT OF LABORATORY-DEVELOPED TESTS
Sens. Edward Kennedy (D-Mass.) and Gordon Smith (R-Ore.) introduced the "Laboratory Test Improvement Act," which will mandate that all providers of laboratory-developed, or "homebrew," tests provide the FDA with evidence of the tests' analytical and clinical validity.
All information about the tests submitted to the FDA will be compiled into a database that will be made available to the public on the internet, the lawmakers said.
The bill would also allow for the enhanced reimbursement of cleared and approved tests.
KEYWORDS FDAnews Device Daily Bulletin
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