On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products.

Software is computer code that tells a computer how to perform a specific task. There are many kinds of software, including operating systems, applications, and malware. Software can be distributed ...

Already under the current MDD regime, medical devices, such as stand-alone MDSW, are classified according to their intended purpose and their inherent risks, and are divided into the following four ...