FDA’s Laboratory-Developed Test Rules Spur Compliance Concerns

Bloomberg Law (5/13, Phengsitthy, Subscription Publication) reports, “The FDA’s final rule to regulate lab-developed tests carved out certain diagnostics from its full scrutiny, creating exceptions that are spurring compliance concerns from some industry members.” The FDA’s final rule “possibly sparked confusion” when the agency “granted exceptions for some” in vitro diagnostics “made by laboratories that weren’t in the proposed rule. The agency determined that tests – such as ones made within a health-care system for unmet needs, or currently marketed IVDs offered as LDTs marketed before the final rule – will face a specialized enforcement discretion.”