medical device regulation

Trade association raises concern that new regulatory system is not ready to support the transition of technology.

This week at the EIT Health Summit in Paris entrepreneurs, industry players, regulators and investors came together to discuss the opportunities for health innovation in Europe, and its relationship to the US market. 

by Bradley Merrill Thompson Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea.

As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory.