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

FDA’s ‘Clearly Very Concerned’ About Delta COVID-19 Variant, CDRH’s Shuren Says

Executive Summary

US FDA device center director Jeff Shuren said on 22 July that the agency is worried about the Delta variant, but is taking the steps necessary to ensure that coronavirus diagnostics give accurate readings.

You may also be interested in...



Coronavirus Variants Spur FDA To Write New Guidance For COVID-19 Test Developers

The US agency’s immediately-in-effect guidance document – released on 22 February – explains how makers of COVID-19 diagnostics can assess whether their tests are impacted by mutations of the virus.

Compliance Corner: Don’t Sign (Or Even Hear) That Affidavit!

Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.

FDA Schedules 2 More Virtual Town Halls In October For COVID-19 Diagnostics

The US agency has announced two additional webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the coronavirus.

Topics

UsernamePublicRestriction

Register

MT144252

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