Understanding FDA’s 510(k) and De Novo Pathways for Faster Market Access

Recently, the European Commission published a proposal for changes to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). This proposal reflects ongoing efforts to improve how these regulatory frameworks operate in...

How FDA Approval Can Open Doors to International Markets Securing approval from the U.S. Food and Drug Administration (FDA) is a significant milestone for medical device manufacturers. Beyond allowing entry into the U.S. market, FDA approval can also serve as a...