Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
January 12, 2023
December 30, 2024
e078beb2-f4b7-4f16-afb1-98c6aad53b11
Related Documents
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration Staff
Guidance DocumentJanuary 12, 2023Center for Devices and Radiological Health
Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency : Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentSeptember 5, 2023Center for Devices and Radiological Health
Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentAugust 11, 2023Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.