Conquering the Mountain: All You Need to Know About the PMA in Medical Devices

Have you ever wondered how those groundbreaking, life-saving medical devices come to be? Often, they reach our doctors’ hands and patient bedsides after scaling a regulatory Everest: the Premarket Approval (PMA) process. This rigorous pathway, overseen by the Food and Drug Administration (FDA), ensures that high-risk medical devices meet the highest standards of safety and […]

FDA’s New RWE Guidance

Real World Results, Real Regulatory Changes: Breaking Down the FDA’s New RWE Guidance The world of medical devices and drugs is constantly evolving, and the way we assess their safety and effectiveness is evolving alongside it. Enter the realm of Real-World Evidence (RWE), stepping out of the controlled environment of clinical trials and into the […]