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December 16, 2021
The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on December 15, 2021. To view listings for other dates, see CDRH New - News and Updates.
- Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Guidance: Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
- Federal Register: Medical Devices: Neurological Devices; Classification of the Traumatic Brain Injury Eye Movement Assessment Aid
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SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
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ASCA-Accredited Testing Laboratories (Updated)
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