The U.S. Food and Drug Administration on June 14 filed a notice of proposed rulemaking with the White House Office for Management and Budget (OMB) regarding the oversight of laboratory-developed tests (LDTs).
Following a lack of congressional action on the Verifying Accurate Leading-edge IVCT Development (VALID) Act [H.R.2369] in 2022, the FDA indicated it would move forward with the formal regulatory process. The proposed rule seeks to amend the FDA regulations to explicitly include LDTs as devices under the Federal Food, Drug, and Cosmetic Act. Specific provisions outlined in the VALID Act would not be implemented under the proposed regulation.
The OMB is expected to conclude its review of the proposed rule by early September 2023 and to then release the regulation for public comment. The FDA would then have two years to finalize the regulation for implementation.
The VALID Act was reintroduced in the House by Rep. Larry Bucshon, M.D. (R-Indiana) at the end of March 2023. It was subsequently referred to the House Energy & Commerce Committee Subcommittee on Health.
Sources:
https://www.cap.org/advocacy/latest-news-and-practice-data/june-20-2023#story2
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202304&RIN=0910-AI85
