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- FDA Sends Final LDT Rule to the White House for Review
On March 1, the Food and Drug Administration (FDA) sent a draft of the final laboratory-developed tests (LDT) regulation to the White House’s Office of Management and Budget (OMB) in the Office of Information and Regulatory Affairs for review. This signals that the FDA has finalized its review of 6,707 comments they received on the proposed rulemaking on LDTs.
The FDA plans to finalize the LDT rule by April 2024, according to a work plan published by the OMB.
Citing substantial undue regulatory burdens and costs on laboratories, the CAP called on the FDA to make significant changes to its proposed regulation of LDTs in a letter to the FDA on December 4.