Thursday, March 14, 2024

FDA LDT ON HILL: Senate Requests Information ASAP on Lab Regulation

 Senator Cassidy has requested public input on regulation of laboratory tests.  The deadline for written documents is April 3, but I've also heard there may be a hearing as early as March 21.  Stay tuned.


Update; House holds hearing on March 21 - here.


See the Senate HELP RFI press release here:

See the full link and a detailed question list. See coverage at Genomeweb.

Here's a summary (AI):

U.S. Senator Bill Cassidy, ranking member of the Senate HELP Committee, has initiated a request for stakeholder feedback on reforming the regulation of clinical tests in the United States. Highlighting the critical role of clinical diagnostics in healthcare and the lack of significant regulatory updates since 1976, Cassidy criticizes the FDA's recent attempts at unilateral regulatory reform as overreach. He seeks insights to guide Congress in modernizing regulations to encourage innovation and maintain safety and effectiveness in diagnostics, including the use of AI and the expansion of test settings. Cassidy's request emphasizes the need for a balanced approach to oversight. Feedback is due by April 3, 2024.