Sen. Cassidy Seeks Feedback on the Regulation of Clinical Tests
U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, is seeking feedback from stakeholders on ways to improve the regulation of clinical tests in the United States.
Since the Medical Device Amendments (MDA) of 1976 established the Food and Drug Administration’s (FDA) framework for medical devices more than 50 years ago there have been major advancements in in vitro diagnostic technologies that have required improvements to the framework. Similarly, advances in clinical laboratory medicine in the 35 years since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were enacted demand standards that reflect advances in molecular and genetic testing, as well as appropriate oversight of tests.
While Congress has considered proposals to reform these regulations, there have been no substantive updates to either of these frameworks. Sen. Cassidy is seeking feedback from stakeholders on potential updates to the FDA regulatory framework for diagnostics and the CLIA Regulatory Framework for LDTs, in particular, actions Congress should take to support innovation and ensure patient access to timely and advanced diagnostics.
Sen. Cassidy has asked 10 questions about each set of regulations, such as how well they are currently working, whether updates are needed, areas in need of improvement, and the regulatory burden of any updates to the regulations. The request for information can be found here and responses should be provided by April 3, 2024.
