Tag: test regulation

Experts slam CAM lab tests, call for better regulation

Experts review the evidence and find that common CAM lab tests have "little or no clinical benefit" and are "a potential risk to patient safety." Regulatory reform is urgently needed to protect the public.

/ March 14, 2019

New FDA regulatory role threatens bogus diagnostic tests

The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it...

/ January 15, 2015