View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
May 22, 2020

US FDA releases list of withdrawn Covid-19 antibody tests

The US Food and Drug Administration (FDA) has published a list of antibody tests that are being removed from the ‘notification list’ of tests to be offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

The US Food and Drug Administration (FDA) has published a list of antibody tests that are being removed from the ‘notification list’ of tests to be offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

Free Report
img

Build resilience in the face of COVID-19 disruption

COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
by GlobalData
Enter your details here to receive your free Report.

The removal list includes antibody tests voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those that do not have a pending emergency use authorisation (EUA) request or issued EUA.

The FDA also noted that antibody tests offered by commercial manufacturers, outlined under the policy issued on 16 March and updated on 4 May, will remain on the notification list pending review of their EUA request.

The move is expected to protect the public health and safety of consumers. The tests on the removal list are prohibited by the FDA from marketing or distribution.

FDA Commissioner Stephen Hahn said: “Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests.

“We have seen a high level of collaboration and engagement from developers who want to get this right and we continue to be available to work extensively with industry to help them with developing accurate tests for the public.”

Earlier this month, the agency updated revised guidance, recommending that commercial manufacturers of antibody tests submit a EUA request within ten business days from the date they notified FDA of their test validation or the date of publication of the revised policy.

As part of the effort to combat the Covid-19 pandemic, the agency will continue to provide timely information to the American public.

Related Companies

Free Report
img

Build resilience in the face of COVID-19 disruption

COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network