Examples of Device Software Functions the FDA Regulates

This list provides examples of software functions that are considered medical devices and on which the FDA will focus its regulatory oversight. These types of software meet the definition of device in the Federal Food, Drug, and Cosmetic Act and their functionality poses a risk to a patient's safety if the software were to not function as intended. Each example below provides a list of possible relevant product code(s) and/or regulation number. The term "software functions" includes mobile applications (apps).

The FDA also encourages software manufacturers to search the 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 Device software function example page for a list of examples of FDA-approved or -cleared software.

Appendix C in the guidance includes examples of software that are considered to be medical devices. As part of the FDA's ongoing effort to provide clarity to software manufacturers, this page includes some of those examples:

Software functions (typically mobile apps) that transform a mobile platform into a regulated medical device and therefore are the focus of the FDA's regulatory oversight: 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 of software functions 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, DSH (21 CFR 870.2800).
• 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)).
• 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 870.5210).
• 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).
• 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).
• 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).
• 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 (21 CFR 882.5050), BZQ, MNR, PRK (21 CFR 868.2375), FLS, NPF (21 CFR 868.2377).
• 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).
• 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 (21 CFR 864.9165).
• Use an attachment to the mobile platform to measure blood glucose levels. Possible product code: NBW (21 CFR 862.1345).
• 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).
• Use a microphone or speaker within a mobile platform to serve as a audiometer to allow healthcare professionals to determine hearing loss at different frequencies. Possible product code: EWO (21 CFR 874.1050).
• 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.

Software functions that connect to an existing device type for purposes of controlling its operation, function, or energy source, and therefore are the focus of the FDA's regulatory oversight: These software functions 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 of software functions 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.
• 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).
• Control or change settings of an implantable neuromuscular stimulator. Possible product code(s): GZC (21 CFR 882.5860).
• Calibrate, control, or change settings of a cochlear implant. Possible product code(s): MCM.
• 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).
• 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).

Software functions that are used in active patient monitoring or to analyze patient-specific medical device data and therefore are the focus of the FDA's regulatory oversight, including software functions that:

• Acquire or process physiological signals that connect to bedside (or cardiac) monitors for active patient monitoring. Possible product code(s): DSI, MHX, MLD (21 CFR 870.1025), DRT, MWI, MSX, PLB (21 CFR 870.2300).
• Process uterine contraction and fetal heart rate data for remote monitoring of labor progress. Possible product code(s): HGM (21 CFR 884.2740).
• Are intended to process images for diagnostic review may be regulated as a medical image management and processing system. Possible product code(s): LLZ (21 CFR 892.2050).
• Uses a variant call format (VCF) file containing patient-specific genetic variants and mutations identified from a Next Generation Sequencing (NGS) Analyzer and provides recommendations for FDA-approved treatments based on those findings. Possible product code: QIC. 1
• Analyzes patient-specific measurements (e.g., ST-segment elevation or depression as reported on ECG reports and cardiac enzyme laboratory results from the EHR) to identify patients potentially experiencing myocardial ischemia or infarction. 2
• Intended for health care professional management of heart failure patients that analyzes patient-specific medical information (e.g., daily heart rate, SpO2, blood pressure, or other output from wearable product) to predict heart failure hospitalization. 3
• Analyzes the radiologist's reported imaging findings and other patient-specific medical information taken by a health care professional upon admission as input to a stroke triage algorithm that indicates whether to transfer the patient to a major stroke center for an intervention. 4

1 Similar to Example 18 in Section V.C "Examples of Device Software Functions" of the Clinical Decision Support Software Guidance.

2 Similar to Example 23 in Section V.C "Examples of Device Software Functions" of the Clinical Decision Support Software Guidance.

3 Similar to Example 24 in Section V.C "Examples of Device Software Functions" of the Clinical Decision Support Software Guidance.

4 Similar to Example 28 in Section V.C "Examples of Device Software Functions" of the Clinical Decision Support Software Guidance.