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

CLIA

This article was originally published in The Gray Sheet

Executive Summary

Comments are due within 30 days of the March 1 publication in the Federal Register of the Medical Devices Draft Guidance for Clinical Laboratory Improvement Amendments of 1988 Criteria for Waiver. The guidance includes an alternate path to waiver based on user comparability criteria, but also retains methods laid out in the 1995 proposed rule (1"The Gray Sheet" Jan. 29, 2001, p. 3)

You may also be interested in...



CLIA Guidance Allows Firms To Gain Waiver Through User Comparison Studies

Manufacturers seeking waived status for diagnostic tests under user-based criteria will need to perform agreement studies with at least 300 untrained users to show that those users obtain the same results as lab professionals, according to an FDA draft guidance issued Jan. 23.

Breckenridge Eyes First Kyprolis Generic With FDA Approval

Towa’s US-based Breckenridge is aiming for exclusivity with its generic version of Amgen’s Kyprolis – developed with partner Natco Pharma – after obtaining one of the first approvals for several strengths of the treatment for relapsed or refractory multiple myeloma.

Nestlé Sees Importance Of Local Brands In ‘Fragmented’ VMS Market

As Nestlé continues to expand its presence in the VMS market it will not take a brand popular in one country and “force” that name on consumers in a different part of the world, says CEO Mark Schneider.

UsernamePublicRestriction

Register

MT014554

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