The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
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.