The U.S. Food and Drug Administration has released final guidance dealing with medical applications running on mobile devices, including consumer smartphones and tablets. Under the new guidance, the FDA indicates that it intends to treat some apps with the same scrutiny which is applies to traditional medical devices.
This guidance has profound (although not entirely unexpected) impact on app developers exploring and exploiting the use of consumer electronic devices to empower people in medical and healthcare related ares. Under the new guidance, developers must look to the functionality of their software, and where appropriate, submit it to the FDA for review and approval. Typically the line of demarcation depends on whether the application interfaces with a regulated medical device, such as blood-pressure monitoring device, or if the app turns the mobile device into a device for assessing the health of an individual. Unfortunately, these lines are somewhat indistinct thus leaving app developers with open questions about whether apps that may skirt these lines are subject to FDA review or not.
This is an area where the law and regulations will continue to evolve over time. In the meantime, app developers who are venturing into products applications which could potentially fall within the jurisdiction of the FDA need to carefully consider their offering and implications of potential regulation by the FDA.