Many companies, particularly Software-as-a-Service (“SaaS”) and start-up companies, continue to struggle with the concept of export control classification of items with encryption functionality. This ...

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.

The burgeoning field of Software as a Medical Device (SaMD) offers opportunities for innovation in healthcare monitoring and delivery through mobile apps. Regulatory focus by the FDA on "device ...

EMC Corp. late this year plans to ship data classification software that initially will work with unstructured information and eventually support databases as well, a company executive said last week.