Critical Concepts Medical Device Software: Approaches to Determining Risk Classification, Qualification, and Safety and Performance Outcomes
In case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic, the FDA released 4 guidance documents in 2022 alone, on topics ranging […]
FDA Provides Guidance on the Regulation of Multiple Function Products with Some Functions that Fall Outside the Medical Device Umbrella
Author: Suzanne Broussard, PhD | January 5, 2021 The increasing number and complexity of medical devices with several functions prompted FDA to provide medical device manufacturers with premarket and postmarket regulatory guidance. In a nutshell, FDA states that it shall not regulate non-device functions […]
