Medical Devices

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 not intended for diagnostic image review (and include a persistent on-screen notice, such as “for informational purposes only and not intended for diagnostic use”) are medical image communications device under 21 CFR 892.2020, product code LMB. Non-diagnostic uses could include: image display for multidisciplinary patient management meetings (e.g., rounds) or patient consultation. Medical image communications devices are Class I and do not require FDA 510(k) premarket notification. Possible product code  LMD (21 CFR 892.2020) [Added March 12, 2014].
  • 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].

Page Last Updated: 06/04/2014
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