The FDA recently submitted its own proposed rule relating to lab-developed test regulation for review.
Hopes are high that something will finally be done to resolve the LDTs situation this year, however that action may not come from Congress.
While the federal spending bill passed at the end of 2022 will have a large impact on clinical labs, it doesn’t include LDTs reform.
Though Congress didn’t pass VALID as part of the medical devices user fees bill, there’s still a good chance it will pass before year’s end.
Congress reportedly set to pass a stripped-down version of the FDA user fees bill without the VALID Act component regulating LDTs.