FDA expedites review of diagnostic tests to combat COVID-19 Below is copy from the FDA website detailing timeline. It seems as though this process should not take more than a couple of days.
Timeline of FDA support for test developers:
- Since the beginning of January, the FDA has worked with more than 230 test developers who have or are expected to submit requests for FDA emergency authorization of their tests; to date, 20 authorizations have been granted.
- In addition, more than 110 laboratories have notified the FDA that they have begun using their own tests.
- For interested developers, the FDA provided recommendations for how to check a test for accuracy as well as a short form to make it easy to share their test information quickly in support of an Emergency Use Authorization (EUA).
Emergency Use Authorization authorities:
- An EUA, put into place by Congress, is a relaxed standard that allows tests to be made available based on less data than in non-urgent circumstances and allows for expedited FDA review.
- In many cases, the FDA can do this review in as little as a day, which it has done repeatedly.
- EUA authority is not a barrier to test availability.
FDA policy updates:
- The FDA recognized the urgent need for even faster testing availability. Although laboratories could use the EUA pathway, many were hesitant or didn’t know the pathway was available to them.
- To respond to this need, the FDA revised the process to allow labs to begin testing prior to FDA review of their validation data. This policy change was an unprecedented action to expand access to testing. Nevertheless, in the first week, only six laboratories took advantage of this further streamlined process because many laboratories did not have a test, or did not have the viral samples to check the accuracy of their test.
- In addition, the FDA implemented another change to empower states to take responsibility for tests developed and used by laboratories in their states without FDA review.
All the best,