The following examples represent mobile apps FDA considers “mobile medical apps” under the narrow definition it outlined in the draft regulatory guidelines it published this morning. The FDA is seeking comments and feedback from the public. Here are the types of apps the FDA plans to regulate:
Mobile apps that are an extension of one or more medical device(s) by connecting17 to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data. Examples of displays of patient- specific medical device data include remote display of data from bedside monitors, display of previously stored EEG waveforms, and display of medical images directly from a Picture Archiving and Communication System (PACS) server, or similar display functions that meet the definition of an MDDS. Examples of mobile apps that control medical devices include apps that provide the ability to control inflation and deflation of a blood pressure cuff through a mobile platform and mobile apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform.
Mobile apps that transform the mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Examples include a mobile app that uses a mobile platform for medical device functions, such as attachment of a transducer to a mobile platform to function as a stethoscope, attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter, or attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals; or, a mobile app that uses the built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea.
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.
To further clarify, the following categories identify the types of mobile medical apps and their associated classifications.
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 medial 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).
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:
Apps that allow the user to view medical images on a mobile platform and perform an analysis or process for diagnosis;
Apps that connect to DICOM medical image servers and provide processing functions such as pan, zoom, measurement, auto contrasting, automatic detection of features, and other similar functionality;
Apps that analyze, assess, or interpret electrocardiogram or electroencephalogram data;
Apps that connect the mobile platform to vital signs monitors, bedside monitors, cardiac monitors, or other similar devices to:
Be used as a central viewing station for display;
Remotely access vital sign measurements of patients at home;
Be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners;
Record arterial oxygen saturation and pulse rate of adult and pediatric patients inside hospitals and activate an alarm based on changes in levels;
Remotely review other standard or critical real-time numeric data from labor and delivery; o Perform remote Holter monitoring;
Connect to medical imaging devices for displaying, processing or storing medical images;
Wirelessly connect to medical devices and can relay or generate alarms;
Perform remote control, setting changes, or readout via wireless links such as programming or controlling a hearing aid system or implantable or body worn medical device.
Apps that are used as patient screening tools for blood transfusion (extension of Blood Establishment Computer Software (BECS)) or other biologics;
Apps that connect to a home use diagnostic medical device such as a blood pressure meter, body composition analyzer, or blood glucose meter to collect historical data or to receive, transmit, store, analyze, and display measurements from connected devices;
Apps that control a blood-pressure cuff connected to a mobile platform to inflate the cuff and measure a person’s blood pressure; or
Apps that act as wireless remote controls or synchronization devices for MRI or X-Ray machines.
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:
Apps that attach EKG/ECG leads to a mobile platform to collect/analyze/monitor EKG/ECG signals;
Apps that connect wirelessly to a blood glucose tester to display, calculate, trend, convert, or download results to a PDA;
Apps that generate sine signals from 125Hz to 8kHz (8 steps) to check the user’s hearing; • Apps that act as a blood glucose meter by using an attachment to a mobile platform; • Apps that act as an electronic stethoscope by connecting (either via wire or wirelessly) to an external sensor to record, manipulate, or measure sound waves; • Apps that use the mobile platform with or without a sound transducer (microphone) to act as an electronic stethoscope to amplify heart, lung, blood vessel, enteral, and other body sounds;
Apps that use the built-in accelerometer or other similar sensors in a mobile platform to monitor the user’s movement to determine conditions such as sleep apnea, sleep phase, fall detection, or detect motion related to other conditions or diseases or to measure heart rate;
Apps that use the light source from a mobile platform to cure and treat specific conditions, such as acne;
Apps that attach sensors to a mobile platform to measure blood glucose, electrocardiograph, or other similar functions;
Apps that use a mobile platform’s built in features such as light, vibrations, camera, or other similar sources to perform medical functions;
Apps that use a mobile platform to upload electroencephalograph (EEG) recordings and automatically detect seizures;
Apps that use a mobile platform to record response time and accuracy of patients completing a cognitive task and/or automatically score or interpret cognitive testing results;
Apps that use pictures and sound to diagnose conditions by comparing to previously determined diagnoses of images, symptoms, sounds, or other physiological measurements; or
Apps that use a mobile platform in determining blood donor eligibility prior to collection of blood or blood components.
Mobile medical apps that allow the user to input patient-specific information and – using formulae or a processing algorithm – output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions:
Apps that perform calculations intended to be used by clinicians for automating tasks, such as:
eGFR with CKD-Epi, Cockcroft-Gault, and MDRD; o A-a gradient, etc.
Apps that act as calculators or utilize algorithms to produce an index, score, scale, or other similar calculations (e.g., Glasgow Coma Scale, pain index, Apgar score, NIH stroke scale, etc.);
Apps that calculate parameters associated with the use of radioisotopes; • Apps that calculate the amount of chemotherapy needed based on the patient’s Body Surface Area;
Apps that assist with patient-specific dosing, e.g., radiation planning; • Apps that calculate Warfarin Loading and Warfarin Maintenance doses for different anti- coagulation therapies based on nomograms; • Apps that act as calculators to determine the maximum dosage of local anesthesia base on a patient’s weight and age; or
Apps that calculate Osteoporosis Risk Assessment by Composite Linear Estimate (ORACLE score).
Apps that collect blood glucose readings and caloric intake to help manage diabetes by calculating pre-meal insulin dose (Bolus) or Basal adjustments; or
Apps that act as a dosing calculators for a treatment regimen intended for a specific patient population (pediatrics);
Apps that define disease stage or progression, and provide a prognosis of a medical condition or predict a patient’s response to treatment based on a analysis of physiological, laboratory, and other data; or
Apps that provide differential diagnosis tools for a clinician to systematically compare and contrast clinical findings (symptoms/ results, etc.) to arrive at possible diagnosis for a patient.