Advisory Board April 3, 2025
On Monday, a federal judge struck down FDA’s plan to regulate lab-developed tests (LDTs) as medical devices, ruling that the agency did not have the authority to regulate such products. Advisory Board’s Rachael Peroutky details what this could mean for the future of LDT regulation.
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Background
According to STAT, FDA and Congress have tried to regulate LDTs for years without much success.
In 2022, lawmakers were close to passing a bill called the VALID Act that would allow FDA to regulate LDTs through a more flexible, less costly framework, but it was ultimately rejected by Republicans. Although the bill was later re-introduced by the House of Representatives in 2023, it...
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