Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

COVID-19: FDA Warns Of Potential Risks Of Antibody Tests

Executive Summary

The US agency’s decision to allow developers to distribute tests that detect COVID-19 in human blood without going through a clearance process has led to some misleading marketing, the agency warned in two recent statements.

You may also be interested in...



COVID-19: FDA Anticipates Further Serology Test Development

US FDA staff discussed hopes for additional serology and saliva tests for COVID-19, as well as at-home test options, during a 15 April webinar.

Ready, Set, Go: ‘Unprecedented’ FDA Guidance Aims To Unburden Coronavirus Test Makers, Speed Process

The US agency issued a guidance document that significantly lowers regulation of diagnostics used specifically to fight the ongoing COVID-19 pandemic. The new policies give states far more autonomy, allow diagnostics makers to distribute products before an Emergency Use Authorization is issued by the FDA, and permits certain serological tests on the market if they adhere to proper labeling.

Government Report Outlines Costs, Savings Of Major Regs

The US HHS was responsible for the most major regulations over the last few years of any agency, an OMB report shows.

Topics

Related Companies

UsernamePublicRestriction

Register

OM006665

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel