Introduction United States Food and Drug Administration (FDA) regulates all medical devices manufactured in the U.S. The FDA regulations, coupled with European Commission regulations, nearly cover all international distribution of medical devices. However, not all manufactured medical devices go through the same regulations. Depending on the possible risk factors, safety, and reliability of the devices,…
Searching the FDA 510k Database for Regulatory Strategy: What Medical Device Manufacturers Need to Know? The FDA 510k database is an important tool for medical device manufacturers. Understanding how to use it can help you stay compliant with FDA regulations and strategically plan your regulatory strategy in the United States. Perform FDA 510k database search…
Class III Medical Device A series of medical devices are available on the market, and are classified into different sub-categories like Class I, Class II, and Class III devices. As per “the Food and Drug Administration,” the medical devices are classified into these three categories. Out of which, you will get to know about Class…