Changes proposed to Clinical Laboratories Improvement Amendments (CLIA) categories
This article was originally published in Clinica
Executive Summary
The US Health Care Financing Administration has published proposed clarified criteria for waived tests under the Clinical Laboratories Improvement Amendments. In order to be exempt from CLIA, all test systems must either be cleared by the FDA for home use or meet requirements to ensure the test procedure is "simple and not prone to error". While the agency has elaborated in the Federal Register (September 13th) properties it considers meet this description, it is interested in comments on alternatives.