Missing The Point (Of Care): FDA Misreading Of CLIA Waiver Law Undermines Cost-Effective Health Testing
by James A. Boiani, Stuart M. Gerson
Washington Legal Foundation
October 16, 2013
The United States Food and Drug Administration’s (“FDA”) misinterpretation of a single word in the statute establishing standards for granting so-called “CLIA Waivers” has created serious problems for patients and health-care providers alike by restricting access to important diagnostic tests. It is time to fix this problem and bring Americans the health care they deserve and at more reasonable cost.