FDA Issued Final Guidance on Mobile Apps

Today the FDA released a final guidance document outlining the agency's approach to mobile apps.  According to the guidance document, the FDA intends to exercise enforcement discretion for the majority of mobile apps that pose minimal risk to consumer (meaning the FDA will not regulate these apps as medical devices).  These include mobile apps that:

• Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;
• Provide patients with simple tools to organize and track their health information;
• Provide easy access to information related to patients’ health conditions or treatments; 
• Help patients document, show, or communicate potential medical conditions to health care providers; 
• Automate simple tasks for health care providers; or
• Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems.

Instead, the FDA intends to focus its oversight on mobile medical apps that:

• are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
• ransform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.

For more information: Mobile Medical Applications Final Guidance: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf