Step 7: Does the Device Software Functions (DSF) and Mobile Medical Applications (MMA) Guidance Apply?
Based on your responses to the Digital Health Policy Navigator in Steps 1-6, your software function likely meets the definition of a device as defined in section 201(h) of the FD&C Act.
The FDA intends to focus its regulatory oversight to those software functions that are medical devices and whose functionality could pose a risk to a patient's safety if the device were to not function as intended.
The Policy for Device Software Functions and Mobile Medical Applications notes that software functions that meet the definition of a device may be deployed on mobile platforms, other general-purpose computing platforms, or in the function or control of a hardware device. If a software function that meets the definition of a device is deployed on a mobile platform, it may be referred to as a "mobile medical app." The policies described in this guidance are independent of the platform on which they might run, are function-specific, and apply across platforms.
Step 7 will help you determine whether your software function may fall within the FDA's intention to exercise enforcement discretion (meaning that the FDA does not intend to enforce requirements under the FD&C Act at this time) or whether your software function is the focus of the FDA's regulatory oversight as a device.
7.A: Does the software function provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment, without providing specific treatment or treatment suggestions?
FDA INTENDS TO EXERCISE ENFORCEMENT DISCRETION
WHY: These are software functions that supplement professional clinical care by facilitating behavioral change or coaching patients with specific diseases or identifiable health conditions in their daily environment. Examples include software functions that coach patients with conditions such as cardiovascular disease, hypertension, diabetes, or obesity, and promote strategies for maintaining a healthy weight, getting optimal nutrition, exercising and staying fit, managing salt intake, or adhering to pre-determined medication dosing schedules by simple prompting.
Generally, at this time the FDA intends to exercise enforcement discretion for software functions that help patients (that is users) self-manage their disease or conditions without providing specific treatment or treatment suggestions, or automate simple tasks for health care professionals.
Considering your answers to the previous questions, answering "Yes" to Question 7.A suggests the software function may fall within the FDA's intention to exercise enforcement discretion (meaning that the FDA does not intend to enforce requirements under the FD&C Act at this time).
If you are unsure, go to Question 7.B to learn about other device criteria and considerations that may apply to your software function.
LEARN: Policy for Device Software Functions and Mobile Medical Applications (see Section V.B. and Appendix B. for additional information and examples of software functions for which the FDA intends to exercise enforcement discretion)
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
Your product may be a device that is the focus of the FDA's regulatory oversight. Go to Question 7.B.
7.B: Does the software function help patients communicate with health care professionals by supplementing or augmenting the data or information by capturing an image for patients to convey to their health care professionals about potential medical conditions?
LIKELY FDA INTENDS TO EXERCISE ENFORCEMENT DISCRETION
WHY: These software functions either pose little or no risk, or are the sole responsibility of the health care professionals who have experience with them in medical applications. Examples include apps specifically intended for medical uses that utilize the mobile device's built-in camera or a connected camera for purposes of documenting or transmitting pictures (for example, photos of a patient's skin lesions or wounds) to supplement or augment what would otherwise be a verbal description in a consultation between health care professionals or between health care professionals and patients/caregivers.
Generally, at this time the FDA intends to exercise enforcement discretion for software functions that help patients (that is, users) self-manage their disease or conditions without providing specific treatment or treatment suggestions, or automate simple tasks for health care professionals. Considering your answers to the previous questions, answering "Yes" to Question 7.B suggests the software function may fall within the FDA's intention to exercise enforcement discretion (meaning that the FDA does not intend to enforce requirements under the FD&C Act at this time).
If you are unsure, go to Question 7.C to learn about other device criteria and considerations that may apply to your software function.
LEARN: Policy for Device Software Functions and Mobile Medical Applications (see Section V.B. and Appendix B. for additional information and examples of software functions for which the FDA intends to exercise enforcement discretion)
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
Your product may be a device that is the focus of the FDA's regulatory oversight. Go to Question 7.C.
7.C: Does the software function perform simple calculations routinely used in clinical practice?
LIKELY FDA INTENDS TO EXERCISE ENFORCEMENT DISCRETION
WHY: These are software functions that are intended to provide a convenient way for clinicians to perform various simple medical calculations taught in medical schools and are routinely used in clinical practice. This software is generally tailored for clinical use, but retains functionality that is similar to simple general-purpose tools such as paper charts, spread sheets, timers, or generic mathematical calculators. Examples of such general-purpose tools include medical calculators for:
- Body Mass Index (BMI);
- Total Body Water / Urea Volume of Distribution;
- Mean arterial pressure;
- Glasgow Coma Scale score;
- APGAR score;
- NIH Stroke Scale; or
- Delivery date estimator.
Generally, at this time the FDA intends to exercise enforcement discretion for software functions that help patients (that is, users) self-manage their disease or conditions without providing specific treatment or treatment suggestions, or automate simple tasks for health care professionals. Considering your answers to the previous questions, answering "Yes" to Question 7.C suggests the software function may fall within the FDA's intention to exercise enforcement discretion (meaning that the FDA does not intend to enforce requirements under the FD&C Act at this time).
If you are unsure, go to Question 7.D to learn about other device criteria and considerations that may apply to your software function.
LEARN: Policy for Device Software Functions and Mobile Medical Applications (see Section V.B. and Appendix B. for additional information and examples of software functions for which the FDA intends to exercise enforcement discretion)
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
Your product may be a device that is the focus of the FDA's regulatory oversight. Go to Question 7.D.
7.D: Is the software function an extension of one or more medical devices by connecting to such device(s) for the purposes of controlling the device(s) or analyzing medical device data?
LIKELY THE FOCUS OF FDA'S REGULATORY OVERSIGHT
WHY: Software functions that connect to medical devices for the purposes of controlling the device or analyzing device data are device software functions. The device software functions or mobile medical apps need not be physically connected to the regulated medical device (for example, the connection can be wired or wireless). These software functions are controlling the intended use, function, modes, or energy source of the connected medical device.
Examples of software functions that control medical devices include:
- Software that provides the ability to control inflation and deflation of a blood pressure cuff through a mobile platform; or
- Mobile apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform.
The FDA intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient's safety if the device were to not function as intended. Considering your answers to the previous questions, answering "Yes" to Question 7.D suggests the software function is likely the focus of the FDA's regulatory oversight as a device.
LEARN: Policy for Device Software Functions and Mobile Medical Applications (see Section V.A. and Appendix C. for additional information and examples of software functions that are the focus of the FDA's regulatory oversight as a device)
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
Even though you answered "No" to Question 7.D, based on your answers to the previous questions in Steps 1-7, your software function is likely a device that is the focus of the FDA's regulatory oversight. Go to Question 7.E.
7.E: Does the software function transform a mobile platform or general-purpose computing platform into a regulated medical device by using attachments, display screens, or sensors, or by including functionalities similar to those of currently regulated medical devices?
LIKELY THE FOCUS OF FDA'S REGULATORY OVERSIGHT
WHY: Software functions that use attachments, display screens, sensors, or other such similar components to transform a mobile platform or a general-purpose computing platform into a regulated medical device are required to comply with the device classification associated with the transformed platform. Examples of these types of software functions include:
- A software function that uses a mobile platform for medical device functions, such as attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter;
- A software function that uses attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals;
- A software function that uses the built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea; or
- A software function that uses sensors (internal or external) on a mobile platform for creating electronic stethoscope function is considered to transform the mobile platform into an electronic stethoscope.
The FDA intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient's safety if the device were to not function as intended. Considering your answers to the previous questions, answering "Yes" to Question 7.E suggests the software function is likely the focus of the FDA's regulatory oversight as a device.
LEARN: Policy for Device Software Functions and Mobile Medical Applications (see Section V.A. and Appendix C. for additional information and examples of software functions that are the focus of the FDA's regulatory oversight as a device)
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
Even though you answered "No" to Question 7.E, based on your answers to the previous questions in Steps 1-7, your software function is likely a device that is the focus of the FDA's regulatory oversight. Go to Question 7.F.
7.F: Does the software function perform patient-specific analysis and provide specific output(s) or directive(s) to users for use in the diagnosis, treatment, mitigation, cure, or prevention of a disease or condition?
LIKELY THE FOCUS OF FDA'S REGULATORY OVERSIGHT
WHY: These types of functions are similar to or perform the same function as those types of software devices that have been previously cleared or approved. Examples of software functions that perform sophisticated analysis or interpret data (electronically collected or manually entered) from another medical device include:
- Software functions that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy;
- Computer Aided Detection (CAD) image processing software; or
- Radiation therapy treatment planning software.
The FDA encourages manufacturers of such device software functions that perform patient specific analysis to contact the FDA to discuss what, if any, regulatory requirements may apply. The FDA intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient's safety if the device were to not function as intended. Considering your answers to the previous questions, answering "Yes" to Question 7.F suggests the software function is likely the focus of the FDA's regulatory oversight as a device.
LEARN: Policy for Device Software Functions and Mobile Medical Applications (see Section V.A. and Appendix C. for additional information and examples of software functions that are the focus of the FDA's regulatory oversight as a device)
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
Your software function is likely a device that is the focus of the FDA's regulatory oversight. Go to Resources.
WHY: Based on your answers to the previous questions in Steps 1-7, your software function is likely the focus of the FDA's regulatory oversight as a device.
LEARN: We encourage you review the examples in Appendix C. of the Policy for Device Software Functions and Mobile Medical Applications guidance to help determine if your software function is the focus of the FDA's regulatory oversight as a device. We also recommend that you review the FDA's How to Determine if Your Product is a Medical Device webpage.
ASK: Based on your responses, we recommend that you go to Resources to engage with the FDA and receive feedback specific to your product.
If your product contains another software function, go to Step 1 for the next software function.
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