This list provides examples of mobile apps that MAY meet the definition of medical device but for which FDA intends to exercise enforcement discretion. These mobile apps may be intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.  Even though these mobile apps MAY meet the definition of medical device, FDA intends to exercise enforcement discretion for these mobile apps because they pose lower risk to the public.

The FDA understands that there may be other unique and innovative mobile apps that may not be covered in this list that may also constitute healthcare related mobile apps. This list is not exhaustive; it is only intended to provide clarity and assistance in identifying the mobile apps that will not be subject to regulatory requirements at this time.

Appendix B in the guidance includes examples of mobile apps for which the FDA intends to exercise enforcement discretion at the time the guidance was finalized.  As part of FDA’s ongoing effort to provide clarity to mobile app manufacturers this page includes all examples in Appendix B as well as updates with additional examples.

• Mobile apps that help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing a “Skill of the Day” behavioral technique or audio messages that the user can access when experiencing increased anxiety;
• Mobile apps that provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women;
• Mobile apps that use GPS location information to alert asthmatics of environmental conditions that may cause asthma symptoms or alert an addiction patient (substance abusers) when near a pre-identified, high-risk location;
• Mobile apps that use video and video games to motivate patients to do their physical therapy exercises at home;
• Mobile apps that prompt a user to enter which herb and drug they would like to take concurrently and provide information about whether interactions have been seen in the literature and a summary of what type of interaction was reported;
• Mobile apps that help asthmatics track inhaler usage, asthma episodes experienced, location of user at the time of an attack, or environmental triggers of asthma attacks;
• Mobile apps that prompt the user to manually enter symptomatic, behavioral or environmental information, the specifics of which are pre-defined by a health care provider, and store the information for later review;
• Mobile apps that use patient characteristics such as age, sex, and behavioral risk factors to provide patient-specific screening, counseling and preventive recommendations from well-known and established authorities;
• Mobile apps that use a checklist of common signs and symptoms to provide a list of possible medical conditions and advice on when to consult a health care provider;
• Mobile apps that guide a user through a questionnaire of signs and symptoms to provide a recommendation for the type of health care facility most appropriate to their needs;
• Mobile apps that record the clinical conversation a clinician has with a patient and sends it (or a link) to the patient to access after the visit;
• Mobile apps that are intended to allow a user to initiate a pre-specified nurse call or emergency call using broadband or cellular phone technology;
• Mobile apps that enable a patient or caregiver to create and send an alert or general emergency notification to first responders;
• Mobile apps that keep track of medications and provide user-configured reminders for improved medication adherence;
• Mobile apps that provide patients a portal into their own health information, such as access to information captured during a previous clinical visit or historical trending and comparison of vital signs (e.g., body temperature, heart rate, blood pressure, or respiratory rate);
• Mobile apps that aggregate and display trends in personal health incidents (e.g., hospitalization rates or alert notification rates);
• Mobile apps that allow a user to collect (electronically or manually entered) blood pressure data and share this data through e-mail, track and trend it, or upload it to a personal or electronic health record;
• Mobile apps that provide oral health reminders or tracking tools for users with gum disease;
• Mobile apps that provide prediabetes patients with guidance or tools to help them develop better eating habits or increase physical activity;
• Mobile apps that display, at opportune times, images or other messages for a substance abuser who wants to stop addictive behavior;
• Mobile apps¹ that are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness, such as those that:
  • Provide tools to promote or encourage healthy eating, exercise, weight loss or other activities generally related to a healthy lifestyle or wellness;
  • Provide dietary logs, calorie counters or make dietary suggestions;
  • Provide meal planners and recipes;
  • Track general daily activities or make exercise or posture suggestions;
  • Track a normal baby’s sleeping and feeding habits;
  • Actively monitor and trend exercise activity;
  • Help healthy people track the quantity or quality of their normal sleep patterns;
  • Provide and track scores from mind-challenging games or generic “brain age” tests;
  • Provide daily motivational tips (e.g., via text or other types of messaging) to reduce stress and promote a positive mental outlook;
  • Use social gaming to encourage healthy lifestyle habits;
  • Calculate calories burned in a workout.
• Mobile apps for providers that help track or manage patient immunizations by assessing the need for immunization, consent form, and immunization lot number [Added March 12, 2014];
• Mobile apps that provide drug-drug interactions and relevant safety information (side effects,  drug interactions, active ingredient) as a report based on demographic data (age, gender), clinical information (current diagnosis), and current medications [Added March 12, 2014];
• Mobile apps that enable, during an encounter, a health care provider to access their patient’s personal health record (health information) that is either hosted on a web-based or other platform [Added March 12, 2014];
• Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record. [Added June 11, 2014].

¹ When these items are not marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or do not otherwise meet the definition of medical device, FDA does not regulate them.  When they are marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or otherwise meet the definition of medical device, FDA intends to exercise enforcement discretion.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm368744.htm