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

Changes proposed to Clinical Laboratories Improvement Amendments (CLIA) categories

This article was originally published in Clinica

Executive Summary

The US Health Care Financing Administration has published proposed clarified criteria for waived tests under the Clinical Laboratories Improvement Amendments. In order to be exempt from CLIA, all test systems must either be cleared by the FDA for home use or meet requirements to ensure the test procedure is "simple and not prone to error". While the agency has elaborated in the Federal Register (September 13th) properties it considers meet this description, it is interested in comments on alternatives.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT093385

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