JD Supra — Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests
Stakeholders prepare for the U.S. Food and Drug Administration’s (“FDA”) rulemaking effort to “make explicit” that laboratory developed tests (“LDTs”) are devices subject to the agency’s oversight, reigniting outstanding questions of jurisdiction and authority. The Office of Management and Budget’s Office of Information and Regulatory Affairs (“OIRA”) recently received a proposed rulemaking from FDA to regulate LDTs…