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New Waived Tests

This new Article comprises Subregulatory Guidance for new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests the FDA has approved.

Download the Guidance Document

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: April 27, 2021

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.