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- Common Questions Answered About the CAP’s Amicus Brief on LDTs
Our laboratory-developed test (LDT) oversight FAQ webpage now includes commonly asked and answered questions about the CAP’s amicus brief court filing from October 7.
In the amicus brief, the CAP urged a US Federal District Court to vacate the FDA regulation for several reasons, including the ultimate impact on patient access to these critically important diagnostic tests and the FDA failing to adequately justify the rule’s unsustainable costs that will hinder the development of LDTs.