Court Rules FDA Lacks Authority to Regulate
Laboratory-Developed Tests 

A federal judge has ruled that the Food and Drug Administration lacks the legal authority to regulate laboratory-developed tests, handing a victory to clinical laboratories and medical societies, including IDSA, that challenged the agency’s oversight.

It is unclear if the Administration will continue to attempt to regulate LDTs, but for now, laboratories may continue developing and offering LDTs according to longstanding practice.

The legal challenge to the FDA rule was brought by the American Clinical Laboratory Association and the Association for Molecular Pathology and was heard in the U.S. District Court for the Eastern District of Texas. IDSA, along with the American Society for Microbiology and other partner societies, filed an amicus brief in support of the lawsuit. The brief outlined the extensive use of LDTs in diagnosing and managing a wide range of infectious diseases, emphasizing their essential role in patient care and public health. The judge cited the breadth and depth of these examples as part of the rationale for his decision.

IDSA will continue to monitor any FDA or congressional activity on this issue and continue to advocate for policies that protect innovation and patient access to high quality ID testing.

About IDSA
The Infectious Diseases Society of America is a community of more than 13,000 physicians, scientists and public health experts who specialize in infectious diseases. Its purpose is to improve the health of individuals, communities and society by promoting excellence in patient care, education, research, public health and prevention relating to infectious diseases. Learn more at idsociety.org.