CLIA-Waived Test Market Increasing As Public Health Concerns Loom
This article was originally published in The Gray Sheet
Executive Summary
Rapid growth in the adoption of CLIA-waived laboratory tests is causing some unease regarding appropriate use of the tests
You may also be interested in...
Coming Together On CLIA Waivers? Industry Hopes To Recruit Patients, Providers To Push Reform
Diagnostic firms formed the Coalition for CLIA Waiver Reform last month with the goal of enlisting patients, labs and physicians in the fight to turn back what they say are unreasonable FDA standards for a test to gain access to the broader market of “waived” labs.
Coming Together On CLIA Waivers? Industry Hopes To Recruit Patients, Providers To Push Reform
Diagnostic firms formed the Coalition for CLIA Waiver Reform last month with the goal of enlisting patients, labs and physicians in the fight to turn back what they say are unreasonable FDA standards for a test to gain access to the broader market of “waived” labs.
AdvaMed, CMS Take Conflicting Views On FDA Lab Test Waiver Requirements
FDA will need to consider diverging opinions from outside groups as it develops a policy on the requirements for diagnostic test manufactures seeking permission to market assays to laboratories that are under minimal government oversight