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- AMP Files Lawsuit Against FDA by Challenging LDT Oversight Regulation
The Association for Molecular Pathology (AMP) filed a federal lawsuit challenging the FDA and its final rulemaking on the oversight of LDTs on August 19. This is the second lawsuit filed against the FDA and its LDT regulation. The American Clinical Laboratory Association had filed a similar lawsuit on June 4.
In a statement, AMP said they brought this lawsuit because the FDA final rule exceeded the agency’s authority and to avert the significant and harmful disruption to laboratory medicine.
The CAP is reviewing the legal action by AMP, which included an 83-page complaint filed in the US District Court for the Southern District of Texas. Learn more about the CAP’s laboratory-developed test oversight advocacy.