The American Clinical Laboratory Association (ACLA) has submitted a citizen petition to the Food and Drug Administration (FDA), asking the agency to “refrain from issuing draft or final guidance or a proposed or final rule purporting to regulate LDTs [laboratory developed tests] as devices” and to confirm “that LDTs are not devices” under the Food, Drug, and Cosmetic Act. The trade organization argues that FDA lacks the authority to regulate LDTs.
ACLA explains that LDTs “are in vitro assays that clinical laboratories develop, validate, and perform as testing services. Laboratories create LDTs by establishing procedures for performing the tests with reagents and laboratory equipment. The laboratory receives test orders for specific patients, performs the test according to its own procedures, and reports the test results to the authorized persons who ordered them.” According to ACLA, because LDTs are not distributed commercially, “LDTs thus differ from in vitro diagnostic test kits, which commonly are products containing all or most of the components needed to perform a test, such as reagents and equipment, that are packaged and commercially distributed to laboratories, other providers, and, in some cases, consumers.”
The petition notes that FDA has signaled its intent to regulate LDTs despite Congress’s July 2012 enactment of a Food and Drug Administration Safety and Innovation Act provision prohibiting FDA from issuing any draft or final guidance on the regulation of LDTs without providing 60 days’ notice to two congressional committees. Stating that “LDTs are critical to timely and effective patient care,” . . . “reflect the latest research and scientific developments and allow rapid diagnosis and assessment of emergent infectious diseases, among other diseases and conditions,” ACLA contends that “FDA regulation of LDTs as devices would preclude them from serving these critical public health purposes.” In ACLA’s view, laboratory oversight provided by the Clinical Laboratory Improvement Act is sufficient to ensure the continuing validity and reliability of LDTs.