ACLA Challenges FDA’s Regulation of Laboratory-Developed Tests

The American Clinical Laboratory Association (ACLA), a national trade association that represents clinical laboratories, filed a lawsuit against the Food and Drug Administration on Monday challenging the agency’s final rule on laboratory-developed tests. As described in an AABB Regulatory Update, the final rule takes a sweeping approach to categorizing in vitro diagnostic products as LDTs and would subject these tests to medical device regulations and user fees.

According to ACLA, FDA has overstepped its authority by attempting to regulate professional laboratory testing services as medical devices, which are federally regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments. Furthermore, ACLA emphasized that proper legislation, developed through collaboration with Congress and other stakeholders, is essential for appropriately regulating professional testing services.

“The industry remains committed to working with Congress, FDA, and other stakeholders to advance appropriate legislation that preserves the critical role of laboratory diagnostics and ensures that patients continue to have access to lifesaving tests,” ACLA said in a media release.

AABB continues to assess the impact of FDA’s final rule from collection to administration and will provide additional analysis as information becomes available. Those with questions are welcome to contact AABB at regulatory@aabb.org.