JD Supra

Unpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA

This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The answer is that, on average, the ...
JD Supra

Recent Updates to CLIA Proficiency Testing and Proposed Changes to Fees, Sanctions, and Other Requirements

To maintain the quality of laboratory testing, CLIA requires that laboratories performing moderate or high-complexity testing enroll in an approved proficiency testing program for independent ...
Business Wire

Celerion Achieves Milestone With CLIA Certification for Its Bioanalytical Laboratory, Expanding Capabilities in Clinical Trials and Diagnostic Testing

LINCOLN, Neb--(BUSINESS WIRE)--Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) ...
Seeking Alpha

Roche achieves first CLIA 'Moderate Complexity' categorization for Ionify® 25-Hydroxy Vitamin D total test

INDIANAPOLIS, Sept. 18, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has categorized its Ionify® 25-Hydroxy Vitamin D total ...
Nasdaq

Applied DNA Receives CLIA Certification, Enabling High Throughput Diagnostic COVID-19 Testing

STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that ...
RAPS

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

The US Food and Drug Administration (FDA) on Tuesday issued two draft guidances aimed at updating its recommendations for in vitro diagnostics (IVDs) seeking a waiver from requirements under the ...