FDA Proposes Greater Oversight of Laboratory Developed Tests

In a proposed rule issued on Sept. 29, FDA seeks to strengthen its oversight of laboratory developed tests (LDTs) to improve safety, effectiveness and accuracy of such tests. LDTs are in vitro diagnostic products that the FDA has described as intended for clinical use and designed, manufactured and used within a single clinical laboratory which meets certain laboratory requirements. FDA’s proposed rule would make explicit that in vitro diagnostics are devices under the Federal Food, Drug and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. The rule also outlines the FDA’s plan for phasing out enforcement discretion granted to LDTs. The agency argues that this rulemaking is necessary to address concerns that IVDs offered as LDTs may sometimes provide inaccurate or unreliable results to patients that result in incorrect diagnoses or delayed care. However, many stakeholders have raised concern that the proposed policy change may not ultimately benefit public health and could have implications for timely access to testing services and care. The AOA is currently reviewing the rule and FDA enforcement discretion phaseout plan.