Medtech Insight is part of the Business Intelligence Division 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

CLIA Waiver Authority Shifts To FDA; IVD Office Ready To Test New Methods

This article was originally published in The Gray Sheet

Executive Summary

CDRH is encouraging manufacturers to work with its in vitro diagnostics office to pilot new ways to meet CLIA waiver criteria
Advertisement

Related Content

FDA Draft Guidance Will Aim To Increase CLIA Waiver Flexibility
FDA Draft Guidance Will Aim To Increase CLIA Waiver Flexibility
CLIAC Waiver Criteria Input Readied As FDA Gears Up To Draft Guidance
CLIAC Waiver Criteria Input Readied As FDA Gears Up To Draft Guidance
DCLD Solicits Comments On Quality Control Portion Of CLIA Waiver Guidance
Advertisement
UsernamePublicRestriction

Register

MT020140

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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