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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 ...
(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.
Guardant Health said its blood test to detect cancer that starts in the colon or rectum got an approval from the U.S. Food and Drug Administration, with the test moving closer toward gaining ...
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]
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
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