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by whatshisface
2310 days ago
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>FDA regulates test kits but generally lab developed tests, which are designed and used in single lab, can be offered without FDA review. When HHS declares Public Health Emergency and issues declaration to support EUAs, labs must seek FDA authorization before launching new test. Normally they can be done without approval, but there is a special regulation on the books that activates when the department of health and human services declares a public health emergency. |
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