AHA Dec. 1 urged the Food and Drug Administration not to apply its device regulations to hospital and health system laboratory developed tests. Commenting on a proposed rule that would phase out FDA’s general enforcement discretion approach for most laboratory developed tests, the association said the proposed rule is too broad, does not contain sufficient detail, can potentially increase hospital burden and costs significantly, stifle innovation and decrease hospitals’ ability to provide effective and appropriate care to patients. AHA urged the agency to continue to apply its enforcement discretion to hospital and health system LDTs and defer regulation of the tests mainly to the Centers for Medicare & Medicaid Services' Clinical Laboratory Improvement Amendments program, the College of American Pathologists accreditation and state law, as it currently does.
"These tests are not devices; rather, they are diagnostic tools developed and used in the context of patient care," AHA wrote. "As such, regulating them using the device regulatory framework would have an unquestionably negative impact on patients’ access to essential testing. It would also disrupt medical innovation in a field demonstrating tremendous benefits to patients and providers."