In this week’s roundup: A 19th notified body is designated and more news from Europe; an FDA advisory panel pans the first drug-coated balloon seeking to treat critical limb ischemia; COVID lessons considered by FDA and IMDRF; Brazil electronic instructions-for-use enforcement; CMS administrator nomination imminent and more personnel news.
Notified body, expert panel, and Eudamed news in Europe. An FDA panel votes against BD’s Lutonix paclitaxel-coated balloon as a first-in-class therapy for below-the-knee critical limb ischemia. FDA and the International Medical Device Regulators Forum reflect on COVID-19 lessons. That news and more in this week’s Pathways’ Picks.