FDA regulation digital health

By Heather Mack December 13, 2016
When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show how something truly operates in everyday life. But, according to a panel at the Connected Health conference in Washington, D.C, digital health tools that generate a trove of data could put us on...
By Brian Dolan June 24, 2014
On Friday the FDA issued a draft guidance document that revealed the agency intends to further deregulate medical device data systems (MDDS) and some medical image transfer systems. The FDA wrote that these types of devices are so low risk that they won't be regulating them at all. Examples of health software platforms that have class 1 medical device clearance as an MDDS includes Validic's...