FDA Toughens Requirements for New COVID-19 Tests as HHS Reverses Trump Policy on LDT Reviews
November 17, 2021 at 08:16 PM EST
The FDA Nov. 15 toughened its requirements for COVID-19 tests, including laboratory-developed tests (LDTs), announcing that it will issue emergency use authorizations (EUAs) for only a few types of tests and will require marketing authorization for other tests through traditional device review pathways such as premarket notifications (510(k)s) and de novo classifications.
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