Regulation of cost-effectiveness claims based on consumer sophistication suggested by CDRH's Burlington.
This article was originally published in The Gray Sheet
Executive Summary
REGULATION OF COST-EFFECTIVENESS CLAIMS BASED ON CONSUMER SOPHISTICATION LEVEL suggested by FDA Center for Devices and Radiological Health Director Bruce Burlington at a Nov. 8 ECRI healthcare technology assessment conference in Plymouth Meeting, Pennsylvania. "One of the ideas that [FDA] currently [is] considering" for regulation of cost-effectiveness claims, Burlington said, is trying to "accommodate the fact that audiences can be reasonably stratified according to their sophistication."