Introduction If you’re developing a medical device for the U.S. market, one of the first and most important regulatory questions is “Which FDA approval pathway applies to my device?” The United States Food and Drug Administration (FDA) oversees medical devices in the Center for Devices and Radiological Health (CDRH). The FDA categorizes devices based on … Read more

Welcome to Regulatory MedTech Insights your trusted source for insights into the complex world of medical device regulation. Professionals, start-ups, and entrepreneurs seeking clear, actionable, and up-to-date regulatory information in the medical device industry are the target audience for this blog. You are perhaps a regulatory specialist, a quality manager, a medtech start-up, or just … Read more