GUIDANCES
| Type |
Title |
Status |
Date |
|
Premarket, 510(k)
|
Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Commercial Manufacturers, Clinical Laboratories, and Food and Drug Administration Staff
|
Final
|
11/15/2021
|
|
CLIA (Clinical Laboratory Improvement Amendments), IVDs (In Vitro Diagnostic Devices), Immunology & Microbiology
|
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Developers and Food and Drug Administration Staff
|
Final
|
11/15/2021
|
|
Electronic Submissions
|
Center for Biologics Evaluation and Research
|
Final
|
11/12/2021
|
|
Premarket, Digital Health
|
Center for Devices and Radiological Health
|
Draft
|
11/04/2021
|
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