Laboratory Test Complexity - Waived, Moderate and High
How can I verify the test complexity designation for a particular laboratory test?
Any examples are for illustrative purposes only.
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the FDA's database:
Manual:
Ambulatory
Chapter:
Waived Testing WT
First published date: April 11, 2016
This Standards FAQ was first published on this date.
This page was last updated on November 01, 2021
Get Extra Help with Books and E-books
Browse our gallery of books and e-books to find trusted prep and readiness resources, practical checklists and toolkits, and resources on specialized health care topics.
Stay Informed with Online Education
Online education is the most convenient and cost-effective way to educate your staff and minimize expenses without the need to leave your organization.
Reach Your Safety Goals with eProducts
Assessing and sustaining compliance with accreditation standards or CMS CoPs can be a challenge, but it doesn’t have to be. Rely on our proven software solutions developed by our team of industry experts.
Joint Commission Virtual Assistant