Day: May 10, 2018

In continuation of its efforts to simplify and limit regulation of digital health products, specifically software application that can be used for health-related outcomes, FDA released two new documents this week. Its guidance document on multiple-function devices, namely devices that are used both for regulated and non-regulated functions; FDA describes how it intends to only … Read more

Yesterday FDA took an unprecedented action of filing complaints in Federal courts seeking permanent injunctions to stop two stem cell treatment groups from selling stem cell products, a decision that affects more than 100 clinics in almost 40 states. These two groups were in the news last August when they were raided by FDA inspectors … Read more