Medical Devices

Examples of MMAs That Are NOT Medical Devices

This list provides examples of mobile app functionalities to illustrate the types of mobile apps that could be used in a healthcare environment, in clinical care or patient management, but are not considered medical devices. Because these mobile apps are not considered medical devices, FDA does not regulate them.  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 when a mobile app is not considered to be a medical device.

Appendix A in the guidance includes examples of mobile app functionalities not considered medical devices 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 A as well as updates with additional examples.

  1. Mobile apps that are intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities. These are not devices because these apps are intended to be used as reference materials and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by facilitating a health professional’s assessment of a specific patient, replacing the judgment of clinical personnel, or performing any clinical assessment.   Examples include mobile apps that are:
    • Medical dictionaries;
    • Electronic copies of medical textbooks or literature articles such as the Physician’s Desk Reference or Diagnostic and Statistical Manual of Mental Disorders (DSM);
    • Library of clinical descriptions for diseases and conditions;
    • Encyclopedia of first-aid or emergency care information;
    • Medical abbreviations and definitions;
    • Translations of medical terms across multiple languages.
       
  2. Mobile apps that are intended for health care providers to use as educational tools for medical training or to reinforce training previously received.  These may have more functionality than providing an electronic copy of text (e.g., videos, interactive diagrams), but are not devices because they are intended generally for user education and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by facilitating a health professional’s assessment of a specific patient, replacing the judgment of clinical personnel, or performing any clinical assessment.  Examples include mobile apps that are:
    • Medical flash cards with medical images, pictures, graphs, etc.;
    • Question/Answer quiz apps;
    • Interactive anatomy diagrams or videos;
    • Surgical training videos;
    • Medical board certification or recertification preparation apps;
    • Games that simulate various cardiac arrest scenarios to train health professionals in advanced CPR skills.
    • Digital education tools, quizzes, games, and questionnaires that help engage patients to actively participate in their general health and wellness (calorie consumption, benefits of physical activity). [Added March 12, 2014].
       
  3. Mobile apps that are intended for general patient education and facilitate patient access to commonly used reference information. These apps can be patient-specific (i.e., filters information to patient-specific characteristics), but are intended for increased patient awareness, education, and empowerment, and ultimately support patient-centered health care.  These are not devices because they are intended generally for patient education, and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by aiding clinical decision-making (i.e., to facilitate a health professional’s assessment of a specific patient, replace the judgment of a health professional, or perform any clinical assessment).  Examples include mobile apps that:
    • Provide a portal for healthcare providers to distribute educational information (e.g., interactive diagrams, useful links and resources) to their patients regarding their disease, condition, treatment or up-coming procedure;
    • Help guide patients to ask appropriate questions to their physician relevant to their particular disease, condition, or concern;
    • Provide information about gluten-free food products or restaurants;
    • Help match patients with potentially appropriate clinical trials and facilitate communication between the patient and clinical trial investigators;
    • Provide tutorials or training videos on how to administer first-aid or CPR;
    • Allow users to input pill shape, color or imprint and displays pictures and names of pills that match this description;
    • Find the closest medical facilities and doctors to the user’s location;
    • Provide lists of emergency hotlines and physician/nurse advice lines;
    • Provide and compare costs of drugs and medical products at pharmacies in the user’s location.
    • Provide access to education materials using digital media to help patients cope with stress [Added March 12, 2014].
       
  4. Mobile apps that automate general office operations in a health care setting and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Examples include mobile apps that:
    • Determine billing codes like ICD-9 (international statistical classification of diseases);
    • Enable insurance claims data collection and processing and other apps that are similarly administrative in nature;
    • Analyze insurance claims for fraud or abuse;
    • Perform medical business accounting functions or track and trend billable hours and procedures;
    • Generate reminders for scheduled medical appointments or blood donation appointments;
    • Help patients track, review and pay medical claims and bills online;
    • Manage shifts for doctors;
    • Manage or schedule hospital rooms or bed spaces;
    • Provide wait times and electronic check-in for hospital emergency rooms and urgent care facilities.
    • Allow healthcare providers or staff in healthcare setting to process payments (for example a HIPAA compliant app); [Added March 12, 2014].
    • Track or perform patient satisfaction survey after an encounter or a clinical visit [Added March 12, 2014].
       
  5. Mobile apps that are generic aids or general purpose products. These apps are not considered devices because they are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.  Examples include mobile apps that:
    • Use the mobile platform as a magnifying glass (but are not specifically intended for medical purposes1);
    • Use the mobile platform for recording audio, note-taking, replaying audio with amplification, or other similar functionalities;
    • Allow patients or healthcare providers to interact through email, web-based platforms, video or other communication mechanisms (but are not specifically intended for medical purposes);
    • Provide maps and turn-by-turn directions to medical facilities;
    • Allow health care providers to communicate in a secure and protected method (for example HIPAA compliant [Added March 12, 2014].

1 Medical purpose magnifiers are regulated either under 21 CFR 886.5840 - Magnifying spectacles ("devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images"), or under 21 CFR 886.5540 - Low-vision magnifiers ("a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles").

Page Last Updated: 06/04/2014
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