There’s an App for That
US Legislator Proposes New Office to Regulate Mobile Apps
Overview of Regulatory Requirements
The FDA Premarket Approval Process for Medical Devices for commercial release within the United States
Definition of a Medical Device
Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as “any instrument, machine, contrivance, or implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, and diagnose disease in man”.