To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

The Illinois lawmakers want an electronic format for medical device makers to quickly and transparently report recall ...

FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...

The Food and Drug Administration (FDA) Breakthrough Devices Program was created by the Congress in the 21st Century Cures Act of 2016. The program is designed to accelerate the development, assessment ...