The American Hospital Association is urging the FDA not to move forward with a proposed rule to treat laboratory-developed tests as medical devices, saying the move would disrupt innovation and potentially increase hospital costs.
The FDA issued a proposed rule Sept. 29 to strengthen its oversight of the lab tests and treat them as medical devices. Laboratory-developed tests, or LDTs, are those designed, manufactured and used within a single clinical laboratory, often in hospital and academic medical center labs. Federal regulators estimate such tests are the basis for 70% of medical decisions made in the U.S. When inaccurate, results can lead to patients receiving unnecessary treatment, delaying treatment, or forgoing treatment altogether, according to the FDA.
In a Dec. 1 comment on the proposed rule, the AHA said LDTs are not medical devices and are "critical in providing timely patient access to accurate and high-quality testing" for a broad range of conditions, including those for which no commercial test exists.
"We strongly believe the FDA should not apply its device regulations to hospital and health system LDTs," the AHA said in a letter to the FDA. "These tests are not devices; rather, they are diagnostic tools developed and used in the context of patient care. 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."
Instead, the FDA should give hospital and health system LTDs enforcement discretion, the AHA said, adding it should continue to 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.
In reacting to the proposal, some experts have said the proposal addresses one of the most significant regulatory gaps remaining at the FDA, while critics, such as those representing academic medical centers, argue such regulation could stifle innovation and impose redundant compliance requirements on hospitals.