CAP to Trump Transition: Dump FDA LDT Regulation

College of American Pathologists has sent two letters, one to Congress and one to the Trump Transition team, asking that the FDA regulation of LDTs, in its current form, be stopped.

• The CAP Webpage is here.
• The CAP letter to Trump Transition is here.  November 19.
• The CAP letter to Congress is here.  November 20.

The presidential take-home message is pretty direct:

• The CAP urges the Trump Administration to rescind the regulation and work with Congress to enact legislation to establish a regulatory framework at the FDA uniquely tailored to diagnostic tests.

And for the Hill:

• The College of American Pathologists (CAP) urges [Congress] to include legislation in an end-of-year package preventing the implementation of the U.S. Food and Drug Administration’s (FDA) “Medical Devices; Laboratory Developed Tests” final rule.