COLA has established this FDA Updates page so that you can quickly receive up to date information from the FDA for clinical laboratories.

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.