The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery.
Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. These tools are being adopted almost as quickly as they can be developed. According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications (http://www.research2guidance.com/500m-people-will -be-using-healthcare-mobile-applications-in-2015/). These users include health care professionals, consumers, and patients.
The FDA encourages the development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps.
The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff(PDF – 269KB) on September 25, 2013, which explains the agency’s oversight of mobile medical apps as devices and our focus only on the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.
What are mobile medical apps?
Mobile apps are software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software.
Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.
Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance. For example, the National Institutes of Health’s LactMed app provides nursing mothers with information about the effects of medicines on breast milk and nursing infants.
Other apps aim to help health care professionals improve and facilitate patient care. The Radiation Emergency Medical Management (REMM) app gives health care providers guidance on diagnosing and treating radiation injuries. Some mobile medical apps can diagnose cancer or heart rhythm abnormalities, or function as the “central command” for a glucose meter used by an insulin-dependent diabetic patient.
How will the FDA regulate mobile medical apps?
The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices. The guidance document (PDF – 269KB) provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A, Appendix B and Appendix C.
We encourage app developers to contact the FDA – as early as possible – if they have any questions about their mobile app, its level of risk, and whether a premarket application is required.
Mobile medical apps that the FDA will regulate
The FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of “device” and that:
- are intended to be used as an accessory to a regulated medical device, or
- transform a mobile platform into a regulated medical device.
Mobile apps span a wide range of health functions. While many mobile apps carry minimal risk, those that can pose a greater risk to patients will require FDA review.
Please visit the mobile medical apps example page for a list of examples of mobile medical apps that have been cleared or approved by the FDA. Visit the Examples of MMAs the FDA regulates webpage for a more detailed list of examples of mobile apps that would require FDA review.
For a list of what is considered a mobile medical application, manufacturers and developers of mobile applications can search FDA’s database of existing classification by type of mobile medical application (for example diagnostic). Approved/cleared mobile medical applications will also be listed in FDA’s 510(k) and PMAdatabases and on the FDA’s Registration & Listing Database.
FDA’s mobile medical apps policy does not require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes.
Mobile apps for which the FDA intends to exercise enforcement discretion
For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:
- Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
- Provide patients with simple tools to organize and track their health information;
- Provide easy access to information related to health conditions or treatments;
- Help patients document, show or communicate potential medical conditions to health care providers;
- Automate simple tasks for health care providers; or
- Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.
For a more detailed list of examples of these types of mobile medical apps that do not require FDA review, please visit the webpage Examples of Mobile Apps for which the FDA will exercise enforcement discretion.
Does the FDA regulate mobile devices and mobile app stores?
FDA’s mobile medical apps policy does not regulate the sale or general consumer use of smartphones or tablets. FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers. FDA’s mobile medical apps policy does not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA.
Does the guidance apply to electronic health records?
FDA’s mobile medical app policy does not apply to mobile apps that function as an electronic health record (EHR) system or personal health record system.
Additional Resources
Examples of MMAs the FDA Regulates
This list provides examples of mobile apps that are considered medical devices (i.e., mobile medical apps), on which FDA will focus its regulatory oversight. These mobile apps meet the definition of medical device in the FD&C Act and their functionality poses a risk to a patient’s safety if the mobile app were to not function as intended. Each example below provides a list of possible relevant product code(s) and/or regulation number.
FDA also encourages mobile medical app manufacturers to search FDA’s public databases, such as the “Product Classification” database and the “510(k) Premarket Notification” database, to determine the level of regulation for a given device and for the most up-to-date information about the relevant regulatory requirements.
Please also visit the mobile medical apps example page for a list of examples of FDA cleared or approved apps.
Appendix C in the guidance includes examples of mobile apps 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 C as well as updates with additional examples.
Mobile apps that transform a mobile platform into a regulated medical device and therefore are mobile medical apps: These mobile apps use a mobile platform’s built-in features such as light, vibrations, camera, or other similar sources to perform medical device functions (e.g., mobile medical apps that are used by a licensed practitioner to diagnose or treat a disease). Possible product codes: Varies depending on the intended use and function of the mobile medical app; see additional examples below.
- Mobile apps that use a sensor or lead that is connected to a mobile platform to measure and display the electrical signal produced by the heart (electrocardiograph or ECG). Possible product code(s): DPS, MLC, OEY (21 CFR 870.2340), MLO, MWJ (21 CFR 870.2800).
- Mobile apps that use a sensor or electrode attached to the mobile platform or tools within the mobile platform itself (e.g., microphone and speaker) to electronically amplify and “project sounds associated with the heart, arteries and veins and other internal organs” (i.e., an electronic stethoscope). Possible product code: DQD (21 CFR 870.1875(b)).
- Mobile apps that use a sensor or electrode attached to the mobile platform or tools within the mobile platform itself (e.g., accelerometer) to measure physiological parameters during cardiopulmonary resuscitation (CPR) and give feedback about the quality of CPR being delivered. Possible product code: LIX (21 CFR 870.5200).
- Mobile apps that use a sensor attached to the mobile platform or tools within the mobile platform itself to record, view, or analyze eye movements for use in the diagnosis of balance disorders (i.e., nystagmograph). Possible product code: GWN (21 CFR 882.1460).
- Mobile apps that use tools within the mobile platform (e.g., speaker) to produce controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders (i.e., an audiometer). Possible product code: EWO (21 CFR 874.1050).
- Mobile apps that use a sensor attached to the mobile platform or tools within the mobile platform itself (e.g., accelerometer) to measure the degree of tremor caused by certain diseases (i.e., a tremor transducer). Possible product code: GYD (21 CFR 882.1950).
- Mobile apps that use a sensor attached to the mobile platform or tools within the mobile platform itself (e.g., accelerometer, microphone) to measure physiological parameters (e.g., limb movement, electrical activity of the brain (EEG)) during sleep and are intended for use in diagnosis of specific diseases or conditions such as sleep apnea. Possible product code(s): OLV (21 CFR 882.1400), LEL, MNR (21 CFR 868.2375), FLS, NPF (21 CFR 868.2377).
- Mobile apps that use an attachment to the mobile platform to measure blood oxygen saturation for diagnosis of specific disease or condition. Possible product code(s): DQA, NLF, MUD, NMD (21 CFR 870.2700) or DPZ (21 CFR 870.2710).
- Mobile apps that present donor history questions to a potential blood donor and record and/or transmit the responses to those questions for a blood collection facility to use in determining blood donor eligibility prior to collection of blood or blood components. Possible product code: MMH
- Mobile apps that use an attachment to the mobile platform to measure blood glucose levels. Possible product code: NBW (21 CFR 862.1345).
- Mobile apps that use that use an attachment to the mobile platform (e.g., light source, laser) to treat acne, reduce wrinkles, or remove hair. Possible product code: OLP, OHT, OHS (21 CFR 878.4810), OZC (21 CFR 890.5740).
- Mobile apps that use a microphone or speaker within a mobile platform to serve as a audiometer to allow healthcare providers to determine hearing loss at different frequencies. Possible product code: EWO (21 CFR 874.1050) [Added March 12, 2014]
- Mobile apps that analyze an image of a skin lesion using mathematical algorithms, such as fractal analysis, and provide the user with an assessment of the risk of the lesion. [Added March 12, 2014]
Mobile apps that connect to an existing device type for purposes of controlling its operation, function, or energy source and therefore are mobile medical apps: These mobile apps are those that control the operation or function (e.g., changes settings) of an implantable or body worn medical device. Possible product codes: Varies depending on the intended use and function of the parent medical device; see additional examples below.
- Mobile apps that alter the function or settings of an infusion pump. Possible product codes: MEB, FRN, LZH, LZG, OPP, MEA (21 CFR 880.5725), FIH (21 CFR 876.5820), LKK.
- Mobile apps that act as wireless remote controls or synchronization devices for computed tomography (CT) or X-Ray machines. Possible product code: JAK (21 CFR 892.1750), IZL (21 CFR 892.1720), KPR (21 CFR 892.1680).
- Mobile apps that control or change settings of an implantable neuromuscular stimulator. Possible product code(s): GZC (21 CFR 882.5860).
- Mobile apps that calibrate, control, or change settings of a cochlear implant. Possible product code(s): MCM.
- Mobile apps that control the inflation or deflation of a blood-pressure cuff. Possible product code: DSJ (21 CFR 870.1100), DSK (21 CFR 870.1110), DXN (21 CFR 870.1130).
- Mobile apps that are used to calibrate hearing aids and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. Possible product code ETW (21 CFR 874.3310) [Added March 12, 2014].
Mobile apps that display, transfer, store, or convert patient-specific medical device data from a connected device and therefore are mobile medical apps:
- Mobile apps that connect to a nursing central station and display medical device data to a physician’s mobile platform for review. (i.e., a medical device data system or MDDS). Product code: OUG (21 CFR 880.6310).
- Mobile apps that connect to bedside (or cardiac) monitors and transfer the data to a central viewing station for display and active patient monitoring. Possible product code(s): DSI, MHX, MLD (21 CFR 870.1025), DRT, MWI, MSX (21 CFR 870.2300).
- Mobile apps that connect to a perinatal monitoring system and transfer uterine contraction and fetal heart rate data to another display to allow for remote monitoring of labor progress. Possible product code(s): HGM (21 CFR 884.2740).
- Mobile apps that are intended to display images for diagnostic review may be regulated as a picture archiving and communications system. Possible product code LLZ, (21 CFR 892.2050) [Added March 12, 2014].
