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

FDA, CDC Address Disease Outbreak Test Development In Wake Of SARS

This article was originally published in The Gray Sheet

Executive Summary

The investigational device exemption process for diagnostic tests related to disease outbreaks should be expedited, FDA acknowledges

You may also be interested in...



Industry, FDA Coordination Key To Diagnostic Test Availability – McClellan

FDA and CDC will coordinate efforts to provide standardized specimens of severe acute respiratory syndrome (SARS) to manufacturers by year-end to aid in validating diagnostics for the disease

Industry, FDA Coordination Key To Diagnostic Test Availability – McClellan

FDA and CDC will coordinate efforts to provide standardized specimens of severe acute respiratory syndrome (SARS) to manufacturers by year-end to aid in validating diagnostics for the disease

SARS Diagnostics Workshop July 14 Would Facilitate Lab Resource Exchange

FDA's device center sees the severe acute respiratory syndrome outbreak as an opportunity to address the scientific challenges of developing new diagnostics when a disease remains ill-defined

UsernamePublicRestriction

Register

LL010986

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