Medtech companies are increasingly looking to the FDA instead of Europe’s CE mark when launching novel products, according to a new report. “Historically, the CE mark has been the preferred route for novel medical technology registration, since its processes were faster, cheaper and more predictable. The situation is now reversed,” wrote the authors of the […]
UCLA Biodesign
How much time and money does it take for FDA 510(k) clearance versus De Novo classification?
If you’re developing a new medical device and want to know how much time and cash it could take to get FDA 510(k) clearance or De Novo classification, a recent report offers some guidance. Boston Consulting Group and the UCLA Biodesign innovation hub questioned leaders at 102 different companies that have achieved registration or approval […]