The new article provides a general overview of the key points related to the inclusion of digital health products in the respective register. Table of Contents The German regulating authority, the Federal institute for Drugs and Medical Devices (BfArM) in the sphere...
The new article addresses the aspects related to modifications to existing medical devices already placed on the market and allowed for use in the US. The document describes in detail various types of changes and explains the way their regulatory status should be...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has developed a guidance document dedicated to the device software functions and mobile medical applications. The latest version of the policy was...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published guidance dedicated to the non-clinical testing and clinical considerations of implanted brain-computer interface devices. The present...