JD Supra

What the New CLIA Rules Mean for Labs and At-Home Testing

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...
Kaleido Scope

Mackinnon named Director, Clinical Laboratory Improvement Amendments Laboratory

Craig Mackinnon, M.D., Ph.D., MSHA, Robert B. Adams Endowed Professor, Division Director, Genomic Diagnostics and Bioinformatics, has been named director of the Clinical Laboratory Improvement ...
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) ...
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) ...
Business Wire

Bluestar Genomics Receives CLIA Certification for Its Clinical Laboratory

SAN DIEGO--(BUSINESS WIRE)--Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy tests initially focused on ...
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 ...
Morningstar

Crown Bioscience San Diego Laboratory Achieves CAP Accreditation, Building on CLIA Certification to Expand Clinical-Grade Capabilities

Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, today announced that its San Diego laboratory has achieved College of American Pathologists (CAP) ...
RAPS

New FDA Guidance Explains the Ins and Outs of the CLIA Categorization Process for IVDs

A new final guidance document released by US medical device regulators makes recommendations on how to comply with the Clinical Laboratory Improvements Amendments (CLIA), a 1988 law that instituted ...