The FDA’s Mobile Medical App Guidance contains many nuanced definitions that determine whether your mobile app will likely be regulated by the FDA as a medical device.Recent clients have asked about the legal status of their mobile health apps, requiring in-depth analysis of the FDA’s position.
In a recent warning letter to Biosense Technologies, FDA stated that the company was marketing the “uCheck Urine” analyzer without medical device clearance: “Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader. When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system. Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).” (emphasis added)
Mobile apps that connect physicians and patients, or, that transmit medical data from the patient to the physician–or particularly, that upload photographs and videos, even if taken with the patient’s smartphone independent of the app–are at risk for FDA regulation as mobile medical apps, and therefore as medical devices.
The FDA has issued Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications (July 11, 2011) (“the Draft MMA Guidance”) to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to a subset of mobile apps—those it calls “mobile medical apps.”
The Draft MMA Guidance defines a “mobile medical app” as: “a mobile app that meets the definition of ‘device’ in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either:
- is used as an accessory to a regulated medical device; or
- transforms a mobile platform into a regulated medical device.”
According to the Draft MMA Guidance:
The intended use of a mobile app determines whether it meets the definition of a device. As stated in 21 CFR 801.4, intended use by may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.
As an example of intended use, the Draft MMA Guidance states that if a light emitting diode (LED) included on a mobile platform with a mobile app is intended to “illuminate objects generally,” then neither the mobile platform nor the mobile app are considered medical devices; on the other hand, if through marketing and distribution, the LED is promoted “as a light source to examine patients,” then the mobile app would meet the definition of a device (and be regulated similar to an opthalmoscope). Furthermore, in general, if a mobile “is intended for use in performing a medical device function,” then it is a medical device, “regardless of the platform on which it is run”—i.e., mobile or desktop.
The Draft MMA Guidance provides examples of mobile apps that FDA does not consider to be mobile medical apps.
These include, among others:
- Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness.
- Mobile apps that perform the functionality of an electronic health record system or personal health record system.
On the other hand, the Draft MMA Guidance gives examples of apps that would likely be considered mobile medical apps for which FDA will apply regulatory oversight. These include:
- Mobile medical apps that are extensions of regulated medical device for purposes of controlling the medical device or for the purpose of displaying, storing, analyzing, or transmitting patient-specific medical device data.
- Mobile medical apps that transform or make the mobile platform into a regulated medical device by using attachments or sensors or similar medical device functions.
- Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.
The Draft MMA Guidance further clarifies by providing categories or types of mobile medical apps, and their associated FDA classifications, as follows:
- Displaying, storing or transmitting patient-specific medical device data in its original format – Mobile medical apps with this functionality constitute an MDDS (21 CFR 880.6310) and are subject to class I requirements (general controls), which include adequate design controls, registration, device listing, adverse event reporting, and corrections and removals. The FDA believes that requiring general controls sufficiently manage the risks for mobile medical apps that are used as a secondary display to a regulated medical device and are not intended for providing primary diagnosis or treatment decisions (i.e. mobile medical apps that meet the MDDS definition).
- Controlling the intended use, function, modes, or energy source of the connected medical device- Mobile medical apps of this type are considered an accessory to the connected device and are required to comply with the controls applicable to that connected device. The FDA considers such a mobile medical app to extend the use and functionality of the connected medical device. As a result, the mobile medical app would be required to comply with the regulations applicable to the connected medical device in order to address any associated risks.
- Transforming or making the mobile platform into a regulated medical device – Mobile medical devices that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform. For example, a mobile medical app that uses sensors (internal or external) on a mobile platform for electronic stethoscope functions is considered to convert the mobile platform into an electronic stethoscope; manufacturers of such a mobile medical app are required to follow the requirements of 21 CFR 870.1875(b) (Electronic Stethoscope). Similarly, a mobile medical app that displays radiological images for diagnosis transforms the mobile platform into a class II PACS under 21 CFR 892.2050. The FDA has already cleared such mobile medical apps.
- Creating alarms, recommendations or creating new information (data) by analyzing or interpreting medical device data – Mobile medical apps of this type that analyze or interpret data (electronically collected or manually entered) from another medical device are considered an accessory to that medical device. These mobile medical apps are generally required to comply with the device classification associated with that other medical device. These types of systems have been previously classified under the same regulations as the connected device; specifically, the decision support tool is treated as an accessory and subject to the same regulatory requirements as the connected device as determined by the connected device’s classification. For example, software that analyzes blood glucose readings to help manage diabetes has been classified as part of a “Glucose Test System” under 21 CFR 862.1345. The FDA has cleared several mobile medical apps with attachments to a mobile platform. Examples include patient monitoring mobile apps that are classified as cardiac monitoring software under 21 CFR 870.2300 (Cardiac monitor). Other mobile medical apps that use a hardware attachment or interface to a monitoring system that have been cleared include an automatic electronic blood pressure monitor (21 CFR 870.1130) and a perinatal monitoring system (21 CFR 884.2740).
Appendix A provides an extensive list of examples of mobile medical apps.
The Draft MMA Guidance defines “regulated medical device” as a medical device that has been classified by the FDA, or other approved or cleared by FDA review of a PMA or other submission for the device; and defines “mobile medical app manufacturer” as any person that manufactures mobile medical apps in accordance with 21 CFR Parts 803 (medical device reporting), 806 (medical devices; reports of corrections and removals); and 807 (establishment registration and device listing for manufacturers and initial importers of devices). Entities that exclusively distribute mobile apps, without engaging in manufacturing functions, are excluded.
Under “Regulatory Requirements,” the Draft MMA Guidance states that manufacturers of mobile medical devices are subject to the requirements described in the applicable device classification regulations. For example:
Class I devices: General Controls, including:
- Establishment registration, and Medical Device listing (21 CFR Part 807);
- Quality System (QS) regulation (21 CFR Part 820);
- Labeling requirements (21 CFR Part 801);
- Medical Device Reporting (21CFR Part 803);
- Premarket notification (21CFR Part 807) unless exempt, or Premarket Approval (PMA) ;
- Reporting Corrections and Removals (21 CFR Part 806); and
- Investigational Device Exemption (IDE) requirements for clinical studies of investigational devices (21 CFR Part 812)
Class II devices: General Controls, Special Controls, and (for most Class II devices) Premarket Notification
Class III devices: General Controls and Premarket Approval (21 CFR Part 814)
Appendix C of the Draft MMA Guidance provides a brief summary of the above requirements, as does the FDA webpage, Device Advice: Comprehensive Regulatory Assistance.
Importantly, the Draft MMA Guidance states that FDA “intends to exercise enforcement discretion” and recommends that all manufacturers of mobile apps that may meet the definition of a device follow the FDA’s Quality Systems regulations (which include good manufacturing practices), and promptly address design errors.
FDA notes that its guidance documents “do not establish legally enforceable responsibilities,” but do “describe the Agency’s current thinking.” To that end, FDA enforcement of its Draft MMA Guidance, to date, is limited, although the FDA tends to read its jurisdiction expansively.
Whenever you are developing a mobile app or other health care technology, be sure to have the FDA medical device legal issues by an attorney who understands FDA legal issues. Contact our FDA lawyers at the Cohen Healthcare Law Group in Los Angeles, California for legal counsel related to your healthcare or medical technology.