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  5. Examples of Software Functions That Are NOT Medical Devices
  1. Device Software Functions Including Mobile Medical Applications

Examples of Software Functions That Are NOT Medical Devices

This list provides examples of software functions to illustrate the types of mobile apps that could be used in a health care environment, in clinical care or patient management, but are not considered medical devices. Because these mobile apps are not considered medical devices, the 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 health care 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 software functions not considered medical devices at the time the guidance was finalized. As part of the 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. Software functions that are intended to provide access to electronic "copies" (for example, 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; and
    • Translations of medical terms across multiple languages.
  2. Software functions that are intended for health care professionals 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 (for example, 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; and
    • Games that simulate various cardiac arrest scenarios to train health professionals in advanced cardiopulmonary resuscitation (CPR) skills.
  3. Software functions that are intended for general patient education and facilitate patient access to commonly used reference information - These apps can be patient-specific (that is, 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 (that is, 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 health care professionals to distribute educational information (for example, 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; and
    • Provide access to education materials using digital media to help patients cope with stress.
  4. Software functions 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 health care professionals or staff in health care setting to process payments (for example a HIPAA compliant app); and
    • Track or perform patient satisfaction survey after an encounter or a clinical visit.
  5. Software functions 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 health care professionals 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; and
    • Allow health care professionals to communicate in a secure and protected method (for example HIPAA compliant app to send messages between health care professionals in a hospital).
  6. Software functions 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 (for example, via text or other types of messaging) to reduce stress and promote a positive mental outlook;
    • Use social gaming to encourage healthy lifestyle habits; and
    • Calculate calories burned in a workout.
  7. Software functions that enable individuals to interact with electronic health record (EHR) software certified under the ONC Health IT Certification Program – These are software functions that provide individuals with access to health record systems or enable them to gain electronic access to health information stored within an EHR system. Software functions that only allow individuals to view, transfer, or download EHR data are also included in this category. These software functions are generally meant to facilitate general patient health information management and health recordkeeping activities:
    • Software functions for health care professionals certified under the ONC Health IT Certification Program, such as those that help track or manage patient immunizations by documenting the need for immunization, consent form, and immunization lot number.
    • Software functions certified under the ONC Health IT Certification Program that prompt the health care professional to manually enter symptomatic, behavioral, or environmental information, the specifics of which are pre-defined by a health care professional, and store the information for later review.
  8. Software functions that enable patients or health care professionals to interact with (for example, transfer, store, convert formats, display data) EHR systems that are certified under the ONC Health IT Certification Program, or interact with a personal health record (PHR) systems.
  9. Software functions that allow a user to record (that is, collect and log) data, such as blood glucose, blood pressure, heart rate, weight, or other data from a device to eventually share with a heath care professional, or upload it to an EHR that is certified under the ONC Health IT Certification Program, or upload it to an online (cloud) database, or upload it to a PHR.
  10. Software functions that provides a list of appropriate cholesterol-lowering drugs to a health care professional to consider based on a patient's cholesterol levels and demographics found in the EHR, and the basis for the recommendations is provided to the health care professional, so the health care professional does not rely primarily on the recommendations in making a clinical decision about a patient.2
  11. Software functions that provide health care professionals easy access to information related to patients' health conditions or treatments (beyond providing an electronic "copy" of a medical reference), and enable the health care professional to independently review the basis of the information provided by the software function, such that the health care professional does not rely primarily on the information to make a clinical decision about an individual patient:3
    • These software functions match patient-specific medical information (for example, diagnosis, treatments, allergies, signs or symptoms) to reference information routinely uses in clinical practice (for example, practice guidelines) to facilitate assessments of specific patients. The software function matches patient-specific medical information to peer-reviewed literature publications on related topics and enables the health care professional to independently review the basis for the information. For example, a software function that uses a patient's diagnosis and other medical information to provide an HCP with current practice treatment guidelines for common illnesses or conditions such as influenza, hypertension, and hypercholesterolemia.4
    • Drug-drug interaction and drug-allergy contraindication notifications to avert adverse drug reactions. These software functions identify drug-drug interactions and drug-allergy contraindications, based on the current version of FDA-approved drug or device labeling or other up-to-date and peer-reviewed sources and patient-specific information, to attempt to prevent adverse drug reactions, and the software functions enable the health care professional to independently review the basis for the information. For example, a software function that identifies drug-disease interactions and contraindications, such as notifying an HCP that a patient with asthma should not be prescribed a non-selective beta-blocking drug.5
  12. Software functions that provide patients with simple tools to organize and record their health information – These are software functions that provide patients with tools to organize and record health information without providing recommendations to alter or change a previously prescribed treatment or therapy. Examples include:
    • Software functions that provide simple tools for patients with specific conditions or chronic disease (for example, obesity, anorexia, arthritis, diabetes, heart disease) to record their events or measurements (for example, blood pressure measurements, drug intake times, diet, daily routine, or emotional state) and share this information with their health care professional as part of a disease-management plan.
  13. Software functions that are specifically marketed to help patients document, show, or communicate to health care professionals regarding potential medical conditions – These products either pose little or no risk, or are the sole responsibility of the health care professionals who have used them in medical applications. Examples include:
    • Software that serves as a videoconferencing portal specifically intended for medical use and to enhance communications between patients, health care professionals, and caregivers.
  14. Software functions that help asthmatics record (that is, collect and log) inhaler usage, asthma episodes experienced, location of user at the time of an attack, or environmental triggers of asthma attacks.
  15. Software functions 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.
  16. Software functions that meet the definition of Non-Device-MDDS6 – These are software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, without controlling or altering the functions or parameters of any connected medical devices. These do not include software functions intended to generate alarms or alerts or prioritize patient-related information on multi-patient displays, which are typically used for active patient monitoring to enable immediate awareness for potential clinical intervention, and are considered device software functions because these functions involve analysis or interpretation of laboratory test or other device data and results.
  17. Software functions that display patient-specific medical device data – These include software functions that display medical images directly from a Picture Archiving and Communication System (PACS) server;
  18. Software functions that are intended for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results and findings. Examples include:
    • Software functions that transfer, store, convert formats, and display medical device data without modifying the data and do not control or alter the functions or parameters of any connected medical devices (that is, software functions that meet the definition of Non-Device-MDDS);
    • Software functions that meet the definition of Non-Device-MDDS and connect to a nursing central station and display (but do not analyze or interpret) medical device data to a physician's mobile platform for review;
    • Software functions that are not intended for diagnostic image review such as image display for multidisciplinary patient management meetings (for example, rounds) or patient consultation (and include a persistent on-screen notice, such as "for informational purposes only and not intended for diagnostic use").

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").

2 Similar to example 9.a in Section V.A "Examples of Non-Device CDS Software Functions" in the "Clinical Decision Support Software" Guidance.

3 Refer to section 520(o)(1)(E) of the FD&C Act and the "Clinical Decision Support Software" guidance for information on the criteria relating to this description.

4 Similar to example 2 a-b in Section V.A "Examples of Non-Device CDS Software Functions" in the "Clinical Decision Support Software" Guidance.

5 Similar to example 4 a-c in Section V.A "Examples of Non-Device CDS Software Functions" in the "Clinical Decision Support Software" Guidance.

6 Non-Device-MDDS is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accordance with the Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices guidance.

 

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