Congress Seeks Feedback on FDA’s LDT Proposed Rule

March 15, 2024

Congress is seeking feedback on the Food and Drug Administration’s proposed regulation of laboratory-developed tests (LDTs). As described in an AABB summary, the proposed rule takes a sweeping approach to categorizing in vitro diagnostic products as LDTs, which would be subject to medical device regulations and user fees.

In the House of Representatives, House Committee on Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) and Subcommittee on Health Chair Brett Guthrie (R-Ky.) announced a subcommittee hearing titled "Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule."  The hearing will take place at 10 a.m. ET on Thursday, March 21, and is available to watch via livestream.

In the Senate, Bill Cassidy, MD, (R-La.), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, requested stakeholder feedback on improving regulation of clinical tests in the U.S. The announcement includes 10 questions related to FDA’s regulatory framework for diagnostics and 10 questions related to the CLIA regulatory framework for LDTs. The deadline to submit feedback is April 3.

In December, AABB urged FDA Commissioner Robert M. Califf, MD, to exclude tests conducted by blood establishments, transfusion services, and accredited cell and gene therapy laboratories from the agency’s proposed regulation. AABB believes that FDA’s proposed regulation does not provide the regulated community with sufficient information to evaluate the potential impact of the proposed rule. Furthermore, AABB believes that the proposed rule would create unnecessary regulatory burdens for some of the urgent, lifesaving LDTs performed by blood establishments, transfusion services, and accredited cell and gene therapy laboratories.

AABB is preparing a submission to share with the Senate HELP Committee and strongly encourages the blood and biotherapies community to provide feedback to shape these comments.