Jamie Ravitz and Paul Gadiock Co-Author Postmarket Benefits Article for FDLI Update Magazine
December 4, 2017
Arent Fox FDA practice group leader Jamie Ravitz and senior attorney Paul Gadiock explore the postmarket performance of medical devices in light of recently released guidance from the FDA in the article, “Capturing Postmarket Benefits in Device Compliance and Enforcement,” published by the Food & Drug Law Institute’s FDLI Update magazine. The article describes how postmarket medical device benefits can be identified and weighed against emerging device risks. Specifically, it explains how benefit evaluations of off-label device use, patient input, and analyses of “alternatives” may be leveraged to counterbalance a potential medical device safety issue so that the manufacturer can continue marketing the product. To read the article in full, click here.