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  5. Examples of Software Functions for Which the FDA Will Exercise Enforcement Discretion
  1. Device Software Functions Including Mobile Medical Applications

Examples of Software Functions for Which the FDA Will Exercise Enforcement Discretion

These software functions may be intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. The term "software functions" includes mobile applications (apps). Even though these software functions MAY meet the definition of medical device, the FDA intends to exercise enforcement discretion for these software functions, because they pose lower risk to the public.

The FDA understands that there may be other unique and innovative software that may not be covered in this list that may also constitute health care related software functions. This list is not exhaustive; it is only intended to provide clarity and assistance in identifying the software for which FDA does not intend to enforce regulatory requirements at this time.

Appendix B in the guidance includes examples of software for which the FDA intends to exercise enforcement discretion. As part of FDA's ongoing effort to provide clarity to software manufacturers, this page includes some of those examples:

  • Software functions 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;
  • Software functions that provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women;
  • Software functions 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;
  • Software functions that use video and video games to motivate patients to do their physical therapy exercises at home;
  • Software functions 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;
  • Software functions 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;
  • Software functions 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;
  • Software functions 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 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;
  • Software functions that keep track of medications and provide user-configured reminders for improved medication adherence;
  • Software functions 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);
  • Software functions that aggregate and display trends in personal health incidents (e.g., hospitalization rates or alert notification rates);
  • Software functions 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;
  • Software functions 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; and
  • Software functions that provide the surgeon with a list of recommended intraocular lens powers and recommended axis of implantation based on information inputted by the surgeon (e.g., anticipated surgically induced astigmatism, patient's axial length and preoperative corneal astigmatism, etc.). [Added August 1, 2016]

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