This study aims to evaluate the health technology assessment ratings for medical devices designated as breakthroughs by the FDA outside the United States.
Cross-sectional study design
Analysis of health technology assessment ratings
Focus on medical devices with FDA breakthrough designations
Identification of varying levels of therapeutic benefit ratings
Characteristics of ratings differ significantly by region
Implications for global standardization of device evaluations
Abstract
This cross-sectional study evaluates the level and characteristics of health technology assessment ratings outside the US for medical devices granted breakthrough designations by the FDA.