RAPS

FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) ...
RAPS

CLIA Waiver Decisions: FDA Begins Posting Summaries

The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part ...
Nasdaq

Axim Biotechnologies Files Pre-Submission With FDA for CLIA Waiver Pathway on Lactoferrin Point-of-Care Diagnostic Test

SAN DIEGO, CA - June 24, 2025 (NEWMEDIAWIRE) - Axim Biotechnologies, Inc. (OTCQB: AXIM), a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has ...

Co-Diagnostics Completes Clinical and Analytical Studies in Preparation for FDA 510(k) Submission of Upper Respiratory Point-of-Care Test

More than 1,400 patients enrolled across 9 clinical sites; analytical performance testing included 27 individual studies and over 10,000 PCR test cup runs Analytical ...
NBC News

OraSure Technologies Submits CLIA Waiver Application for OraQuick(R) HCV Rapid Test

BETHLEHEM, Pa., March 23, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it has submitted to the U.S. Food and Drug Administration ("FDA") an application for a ...
Business Insider

Interview Alert: Experts Available to Comment on Dramatic Increases in CLIA Certificates of Waiver Demonstrate New Trend in Pharmacy Services

FORT WORTH, Texas, July 21, 2021 /PRNewswire/ -- FDS Amplicare, a leading pharmacy technology provider, and its training partners, Don and Mike Klepser, both pharmacy professors and leading experts in ...
JD Supra

CLIA Program Going Paperless March 1st – What You Should Be Doing Now to Prepare

The Centers for Medicare and Medicaid Services (CMS) announced that the Clinical Laboratory Improvement Amendments (CLIA) program will be paperless as of March 1, 2026. After this date, CMS will no ...