Fig. 2From: Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAAUS FDA reviewer trial interpretation and publication, along with a published interpretation of the trial findings, for novel cardiovascular devices approved by the US FDA between 2005 and 2020, pre- and post-FDAAA. US FDA reviewer trial interpretation as positive, equivocal, or negative. A Pre-FDAAA; B Post-FDAAABack to article page