Must FDA Engage in Rulemaking to Regulate Laboratory-Developed Tests?

For more than a year, the Food and Drug Administration (FDA) has been signaling plans to develop a risk-based framework for laboratory-developed tests (LDTs), which largely have been outside of the agency’s regulatory purview. In July 2010 FDA held a public meeting at which officials unveiled plans to regulate clinical laboratories that develop and perform LDTs as “manufacturers” of medical devices and to subject the LDTs to certain of FDA’s medical device requirements, including establishment registration and device listing. More recently, in the context of discussions regarding the reauthorization of the Medical Device User Fee Amendments, FDA confirmed that the agency plans to regulate clinical laboratories and LDTs using a risk-based approach.