FDA Approves the First Commercial Coronavirus Tests in the US

U.S. FDA Regulatory Relief by Accelerated Availability of Diagnostics Facility

U.S. FDA Regulatory Relief by Accelerated Availability of Diagnostics Facility

"We strongly support FDA's decision to abolish its EUA requirements for COVID-19 testing, which will enable many more AACC member laboratories to offer these desperately needed tests", said AACC President Dr. Carmen L. Wiley. At my institution, we've been working with industry partners and accelerating the development of their tests for our patient populations.

The March 16 policy could be the biggest revision yet.

The new measures, among other things, call for states to take responsibility for tests used by labs in the respective states. The labs do not have to engage with the FDA nor will they need to apply for Emergency Use Authorization (EUA). Under the February 29 guidance, the FDA granted EUA waivers to labs that are certified to perform high-complexity testing, but commercial vendors were not covered by that policy. There is a lot of confusion and misinformation about prevention, symptoms, and what to do if you suspect you have contracted the virus or come into contact with someone who has tested positive for novel coronavirus.

The agency stated that serological tests are less complex as compared to molecular diagnostics further highlighting that FDA does not aim to object to the unreviewed applications of serological tests, providing they have been authenticated and comprise warning statements mentioning that they should not be considered as the only way of identifying a COVID-19 infection.

"The policy is meant to achieve a balance between providing regulatory flexibility while allowing for critical scientific rigor", said FDA Commissioner Dr. Stephen Hahn.

Coronavirus: France orders 15-day lockdown, bans public gatherings
Under the lockdown, citizens will need to fill out a form provided by the government, stating their goal for leaving their homes. Macron expressed his disappointment in that people ignored warnings. "There was something shocking about it", he told The Times.

The agency also took steps toward speeding the development of coronavirus test kits by giving states the authority to approve tests developed in laboratories in the states.

The new rules will allow private companies to immediately begin marketing test kits to the public before getting permission from the FDA, as previously required. Now, as a result of the change announced last night by the FDA, the Company's test kit will soon be available for use by and marketed to a wide array of US laboratories, without first requiring Emergency Use Authorization. At this time, the FDA is focused on making sure tests are distributed and that test developers and labs have the materials they need to run the tests. The FDA will then review this data.

Public health experts said Tuesday it was hard to gauge the overall impact of the FDA's latest regulatory changes.

The FDA mentioned that it is closely monitoring the coronavirus outbreak and at the same time collaborating with worldwide & interagency partners and manufacturers & developers of medical products for to help advance response efforts to combat the spread of this deadly virus.

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