The FDA has a wealth of tools that can be helpful for understanding policies and regulations surrounding medical devices and software.
One of the tools many software developers in the health niche find useful is the Digital Health Policy Navigator. This tool includes an in-depth decision flowchart that can help you decide if your health app qualifies as a “device” under the FDA’s definition.
Health apps that meet the definition of a device per section 201(h) of the FD&C Act are subject to regulation by the FDA. These medical mobile applications are treated the same way as physical medical devices and must go through the same approval process before going to market. Apps that don’t fall under this definition or that fall under enforcement discretion are deemed “health apps” and are not regulated by the FDA.
