# Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised):  Guidance for Test Developers and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/policy-for-evaluating-impact-of-viral-mutations-on-covid-19-tests-revised-guidance-for-test-developers-and-food-and-drug-administration-staff/91e43210-583d-46a9-919c-aab24aa0fad0

> FDA guidance document: Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised):  Guidance for Test Developers and Food and Drug Administration Staff. Issue date: January 12, 2023. Get complete insights and analysis.

---

## Details

- Title: Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised):  Guidance for Test Developers and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2023-01-12
- Last Changed: 2024-12-30
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-0987">FDA-2020-D-0987</a>

## Related Documents

- [Certificates of Confidentiality:  Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/certificates-of-confidentiality-guidance-for-sponsors-sponsor-investigators-researchers-industry-and-food-and-drug-administration-staff/2c808a5d-3858-4b85-b669-fc805457803a)
- [Policy for Coronavirus Disease-2019 Tests (Revised):  Guidance for Developers and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/policy-for-coronavirus-disease-2019-tests-revised-guidance-for-developers-and-food-and-drug-administration-staff/e078beb2-f4b7-4f16-afb1-98c6aad53b11)
- [Off-The-Shelf Software Use in Medical Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/off-the-shelf-software-use-in-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/e6562455-523c-4460-ae34-ee4678a33a70)
