Tag: test regulation
Too many lab tests still escape FDA review, threatening patient safety
Even as the lab testing market grows, too many tests escape FDA review based on a meaningless categorization that has nothing to do with patient safety. Congress should pass the VALID Act of 2021, allowing the FDA to adequately regulate direct-to-consumer and other lab tests with the potential to harm the public.
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.
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...