Understanding the Difference:  FDA-Approved vs. FDA-Cleared Medical Devices

Understanding the Difference: FDA-Approved vs. FDA-Cleared Medical Devices

In the fascinating world of medical devices, understanding the distinction between FDA approval and FDA clearance is essential for manufacturers, healthcare providers, and consumers alike. These terms represent different regulatory pathways and levels of scrutiny required by the U.S. Food and Drug Administration (FDA) to ensure the safety and effectiveness of medical devices. What is…