Description
FDA is issuing this guidance to communicate how the Agency intends to apply its regulatory oversight to certain software, including device software functions and mobile medical applications (MMAs) intended for use on mobile platforms or on general-purpose computing platforms. FDA intends to apply its regulatory oversight to those device software functions that meet the definition of a medical device and whose functionality could pose a risk to a patient’s safety if the device were not to function as intended. This guidance describes FDA’s policy for device software functions and MMAs that meet the device definition, including some that are the focus of FDA’s regulatory oversight and some for which FDA does not intend to enforce requirements under the Federal Food, Drug, and Cosmetic Act. This guidance also provides information on some software functions that do not meet the device definition, and as such, are software functions that are not subject to applicable FDA regulatory requirements.
Scope & Applicability
Product Classes
10Software performing medical purposes without being part of hardware
Subject to 21 CFR Part 809
Implantable device calibrated by software
Intended for use in a health care facility to pump fluids and medications.
Software functions solely intended to transfer, store, convert formats, and display medical device data; software functions that meet the definition of Non-Device-MDDS
Subject to General Controls and Premarket Approval
Proposed classification for NGS-based tests for germline diseases.
Subject to General Controls
Software functions within the control of a hardware device
Software function meeting device definition deployed on a mobile platform; Software that meets the definition of a device; software functions that may be subject to reporting or exemptions
Stakeholders
7Entity responsible for manufacturing mobile medical applications; Entity that initiates specifications, designs, or labels a mobile medical app
Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for
Governs top dose in clinical studies
Users of medical software functions
Intended users such as nurses in a nonemergency setting
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Physicians, dentists, and optometrists manufacturing apps for professional practice
Regulatory Context
Attributes
4Type of software components or platforms used in mobile apps
FDA intends to exercise enforcement discretion because they pose lower risk
Criteria used to determine if software is a medical device
Specifications that are directly associated with the intended use of the device.
Identified Hazards
Hazards
3Risk posed if a device software function fails to perform as intended
threshold for requiring a report of correction or removal
Potential risk if software applications do not function as intended
Related CFR Sections (20)
- 21CFR884.2740§ 884.2740 Perinatal monitoring system and accessories.
(a) Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during Read full regulation →
- 21CFR820.1§ 820.1 Scope.
(a) Applicability. Current good manufacturing practice (CGMP) requirements are set forth in this quality management system regulation (QMSR). The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, insRead full regulation →
- 21CFR806.1§ 806.1 Scope.
(a) This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain recordRead full regulation →
- 21CFR806.10§ 806.10 Reports of corrections and removals.
(a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:Read full regulation →
- 21CFR870.1025§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a) Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.Read full regulation →
- 21CFR874.3310§ 874.3310 Hearing aid calibrator and analysis system.
(a) Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The devRead full regulation →
- 21CFR870.1100§ 870.1100 Blood pressure alarm.
(a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.Read full regulation →
- 21CFR882.5860§ 882.5860 Implanted neuromuscular stimulator.
(a) Identification. An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver witRead full regulation →
- 21CFR892.1750§ 892.1750 Computed tomography x-ray system.
(a) Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysiRead full regulation →
- 21CFR876.5820§ 876.5820 Hemodialysis system and accessories.
(a) Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and acceRead full regulation →
- 21CFR880.5725§ 880.5725 Infusion pump.
(a) Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant fRead full regulation →
- 21CFR878.4810§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a) Identification.Read full regulation →
- 21CFR862.1345§ 862.1345 Glucose test system.
(a) Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglRead full regulation →
- 21CFR864.9165§ 864.9165 Blood establishment computer software and accessories.
(a) Identification. Blood establishment computer software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or Read full regulation →
- 21CFR870.2700§ 870.2700 Oximeter.
(a) Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.Read full regulation →
- 21CFR882.1400§ 882.1400 Electroencephalograph.
(a) Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.Read full regulation →
- 21CFR882.1950§ 882.1950 Tremor transducer.
(a) Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.Read full regulation →
- 21CFR874.1050§ 874.1050 Audiometer.
(a) Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.Read full regulation →
- 21CFR882.1460§ 882.1460 Nystagmograph.
(a) Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.Read full regulation →
- 21CFR870.5210§ 870.5210 Cardiopulmonary resuscitation (CPR) aid.
(a) CPR aid without feedback —Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
See Also (8)
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff (Status: Final)
- Deciding When to Submit a 510(k) for a Software Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff (Status: Final)