COLA has established this FDA Updates page so that you can quickly receive up to date information from the FDA for clinical laboratories.
Featured FDA Updates
Recent FDA Updates
Additional Resources:
- FDA’s FAQs on Testing for SARS-CoV-2
This page provides answers to frequently asked questions relating to the development and performance of tests for SARS-CoV-2. These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies. - In Vitro Diagnostics EUAs
To market a laboratory test that can be used in a public health emergency, an Emergency Use Authorization (EUA) from the FDA is needed. - Third Party Review Program
The Third Party Review program is an alternative to a traditional 510(k) pathway the program and is intended to help yield more rapid 510(k) decisions and to allow the FDA to focus its resources on higher-risk devices, while still maintaining oversight of the review of lower-risk devices eligible for Third Party review.