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

HHS Sign-Off Critical To CLIA Waiver Proposal: FDA Criteria At Odds With CMS'

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers seeking CLIA waivers for in vitro diagnostics should wait until FDA's interim guidance is finalized before using the alternative approach it outlines, according to CDRH.

You may also be interested in...



CLIAC Waiver Criteria Input Readied As FDA Gears Up To Draft Guidance

The Clinical Laboratory Improvement Advisory Committee is close to issuing waiver recommendations, after agreeing to largely adopt criteria developed by its CLIA waiver workgroup

CLIAC Waiver Criteria Input Readied As FDA Gears Up To Draft Guidance

The Clinical Laboratory Improvement Advisory Committee is close to issuing waiver recommendations, after agreeing to largely adopt criteria developed by its CLIA waiver workgroup

CLIAC Reaffirms Quality, Comparability In Waiver Criteria Proposal To HHS

Quality control testing requirements should be included in manufacturer instructions for CLIA-waived assays to compensate for the potential inexperience of lab personnel, the Clinical Laboratory Improvement Advisory Committee (CLIAC) is urging HHS

Related Content

UsernamePublicRestriction

Register

LL1132440

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