Changing Our Minds: Reforming the FDA Medical Device Reclassification Process

Powell, SF

Powell, SF (reprint author), United States Dist Court Eastern Dist Tennessee, Knoxville, TN 37902 USA.

FOOD AND DRUG LAW JOURNAL, 2018; 73 (1): 177

Abstract

The United States Food and Drug Administration's (FDA) initial classification decision regarding a medical device has an enormous impact on the cost a......

Full Text Link