Stop Sending EUAs for Covid Diagnostics: FDA
(Thursday, September 29, 2022)
This week, FDA formally announced that it has stopped accepting Emergency Use Authorizations (EUAs) for most Covid diagnostic tests. While this should not come as a surprise to most, this announcement should settle this issue for anyone still hoping to submit an EUA for such tests. EUAs are an important tool for rapidly releasing unapproved products for patient use in cases of national health emergencies, however, these are expected to be temporary provisions, not intended to last more than a year. But most EUAs for Covid diagnostics are in their third year of authorization. About 400 Covid diagnostic test EUAs are still active. Earlier this year, FDA sent a strong message to EUA holders to voluntarily convert their EUAs to full approval under the 510k or PMA pathways, but so far there is little indication that such conversions have happened. Now FDA has announced that no new EUAs will be accepted with very few exceptions. The announcement was made via a revised guidance for legal purposes since the Covid emergency declaration is still active. Legally EUAs can be submitted till the Emergency declaration is withdrawn, so as before, FDA has used a Guidance Document to create new policy regarding a controversial topic. There would be a minimal practical impact of this announcement as, based on publicly available information, no new EUAs have been submitted to the FDA for months, and informally FDA has not been accepting new EUA applications since earlier this year. This announcement seems to be the first step for FDA to force existing EUA holders to either seek full approval or withdraw their EUAs. So far about 33 EUA holders have voluntarily withdrawn their EUAs this year. There are regulatory mechanisms for EUA holders to recycle available data for their products to support 510k applications. But, so far, the EUA holders had little incentive to put the extra effort to do the conversion. It seems that FDA’s liberal policy to let the EUAs get repeat extensions has hurt the 510k program for the same tests. So, FDA is trying to take back the driving seat for “encouraging” (read forcing) the EUA holders to file their 510k applications. The smart ones would do so now when they have the luxury of time, which by the way seems to be running out soon.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC