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 Releases New Tools to Speed COVID-19 Test Development

Executive Summary

The US agency on 29 May gave two additional tools to COVID-19 test developers: an emergency use authorization template for tests using at-home sample collection kits, and a reference panel for the disease.

You may also be interested in...



FDA Releases COVID-19 Test Performance Data

The data compares the sensitivity of almost 200 diagnostics against a standardized set of samples.

FDA Authorizes First At-Home COVID-19 Saliva Sample Collection Kit

The US agency has authorized the first COVID-19 test to use at-home saliva sample collection. Rutgers Clinical Genomics Laboratory landed the emergency use authorization.

App Developers Turning To HIPAA Compliance In Face Of Growing State Data Privacy Constraints

Manufacturers faced with an increasingly complex landscape of state patient-privacy laws may opt to comply with federal Health Insurance Portability and Accountability Act regulations instead, attorney Brad Rostolsky tells Medtech Insight.

Topics

UsernamePublicRestriction

Register

MT142229

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