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- CAP Urges HHS to Heed Executive Order and Revoke FDA LDT Regulation
Following the direction and intent of executive orders signed by President Donald J. Trump, the CAP called on the Department of Health and Human Services (HHS) to terminate the laboratory-developed test (LDT) oversight regulation by the Food and Drug Administration (FDA).
The CAP has opposed the FDA rulemaking and advocated for the administration to rescind the rulemaking by citing significant concerns over extraordinary costs and regulatory burdens on laboratories in an amicus brief filed in October.
CAP members received a special update on legal action against the FDA over the rulemaking on February 19. The oral arguments heard last week regarding the regulation of LDTs. CAP will continue updating members as information becomes available.
While we await further action, CAP members can find additional resources online and register for the next webinar in our LDT series happening March 20.