Ads
related to: fda approved clinical laboratory tests medicare
Search results
Results From The WOW.Com Content Network
(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a new rule that gives it more oversight of diagnostic tests developed by them.
Clinical laboratories in the US that perform high complexity testing require a high complexity laboratory director (HCLD) that has earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS.
Under the government's plan, most newly developed tests that pose a high risk — such as those for life-threatening diseases — will need to be FDA approved within 3 1/2 years. Lower risks tests ...
The Food and Drug Administration (FDA) has recently approved a blood test screening for colorectal cancer that has an over 83% success rate at detecting the presence of this form of cancer.
Direct-to-consumer tests are regulated as medical devices, although they are not necessarily reviewed by the FDA. [8] 23andMe direct-to-consumer genetic tests were originally offered as LDTs, but the FDA challenged that and forced the company to submit the test for approval as a class II medical device. [9] [10]
The Centers for Medicare & Medicaid Services (CMS) is a federal agency within the United States Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children's Health Insurance Program (CHIP), and health insurance portability standards.