• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Evaluation Method Code Hierarchy

Subset: Medical Device Evaluation Methods Terminology

  • ACTUAL DEVICE EVALUATED C91896; FDA 10 - LEVEL 1
  • ACTUAL DEVICE NOT EVALUATED C91897; FDA 3263
    • DEVICE FROM CONTROLLED OR NON-RELEASED SAMPLE EVALUATED C91931; FDA 13
    • DEVICE FROM RESERVE SAMPLE EVALUATED C91932; FDA 12
      • RESERVE SAMPLE FROM DIFFERENT LOT TESTED, NO FAILURE DETECTED C91986; FDA 95
      • RESERVE SAMPLE TESTED FROM SAME LOT, NO FAILURE DETECTED C91987; FDA 3340
    • DEVICE FROM SAME LOT EVALUATED C91933; FDA 11
    • NO TESTING METHODS PERFORMED C91967; FDA 3323 - Testing was not performed on the device.
  • BIOLOGIC EVALUATION C91905; FDA 3269
    • BIOASSAY EVALUATION C91903; FDA 3267 - Measuring the effects of a substance on a living organism. Bioassays may be qualitative or quantitative. Qualitative bioassays are used for assessing the physical effects of a substance that may not be quantified, such as abnormal development or deformity.
    • BIOCOMPATIBILITY TESTING C91904; FDA 3268 - Testing the device to determine if it elicits an undesirable local or systemic biological effect in the cells or tissues of the recipient of that device. This includes testing the device for its toxicity to cells.
    • CONTAMINATION TESTING C91912; FDA 3277 - Testing the device to detect the presence of any substance that can cause infection or fever.
      • AGENT CONTAMINATION TESTING C91900; FDA 3264 - Testing the device for the presence of chemicals or other agents that do not belong on the device (contamination).
      • MATERIAL OR MATERIAL LEACHATE PYROGENIC TESTING C91962; FDA 3319 - Testing the device for the presence of unwanted agents (e.g. pyrogens) caused by materials that permeate through the device.
      • MICROBIAL CONTAMINATION TESTING C91964; FDA 3320 - Testing the device for the presence of microorganisms such as bacteria, viruses, and fungi (yeasts and molds).
    • GENOTOXIC TESTING C91934; FDA 3294 - Testing the device's ability to cause damage to genetic material. (e.g., leading to outgrowths -- malignant tumors).
      • CARCINOGENIC TESTING C91906; FDA 3270 - Testing the device's ability to promote cancer or facilitate its propagation.
      • MUTAGENIC TESTING C91966; FDA 3322 - Testing the device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations.
    • HEMATOLOGIC TESTINGC91938; FDA 3298 - Testing the device for its affect or impact on the blood or its components.
      • AGGLUTINATION TESTING C91901; FDA 3265 - Evaluating the device for characteristics that may cause blood to clot.
      • COMPLEMENT ACTIVATION TESTING C91908; FDA 3274 - Evaluating a device's ability to activate the process of clearing pathogens from a organism.
      • PLATELET ACTIVATION TESTING C91974; FDA 3327 - Testing the device for characteristics that lead to the activation of platelets which are essential to stop bleeding and repair the tissue. Platelets also play a key role in the development of acute coronary syndromes and contribute to cerebrovascular events.
      • THROMBOTIC TESTING C92014; FDA 3363 - Testing the device for characteristics related to forming blood clots along the walls of blood vessels which can cause blockages and affect blood flow through vessels.
    • INTERFERENCE SUBSTANCE TESTING C91950; FDA 3309 - A test used with in vitro diagnostic analytic systems to detect substances that may be interfering with test results and causing errors.
    • PATHOLOGICAL EXAMINATION C91971; FDA 83 - Examining material that may have contributed to the disease or damage. Often performed using a microscope by measuring structural changes that occur along with the disease or damage.
    • REPRODUCTIVE TOXICITY EVALUATION C91985; FDA 3339 - Evaluating a device for chemicals or other agents that may have caused problems with the reproductive system. This includes evaluating a device for chemicals or agents that may have caused or contributed to birth defects or malformations. (teratogenic evaluation)
    • TISSUE ENGINEERING EVALUATION C92015; FDA 3364 - Evaluating a device's characteristics that may affect tissues (e.g. bone, cartilage, blood vessels, bladder).
      • CELL EVALUATION C91907; FDA 3271 - Evaluating a device's characteristics that may affect cells.
      • GROWTH FACTOR EVALUATION C91936; FDA 3296 - Evaluating a device's characteristics that may affect the self healing ability of an organism.
      • SCAFFOLD EVALUATION C91989; FDA 3342 - Evaluating a device's characteristics for its affects on the reproduction of tissues.
  • ELECTRICAL EVALUATION C91919; FDA 23
    • CURRENT LEAKAGE TESTING C91914; FDA 3279 - Testing to detect the amount of electricity leakage from the device.
    • IMPEDANCE TESTING C91944; FDA 3303 - Testing the resistance to current flow in a device's circuit or component.
    • INSULATION TESTING C91949; FDA 3308 - Testing the ability of a device's or component's material to resist the flow of electric current.
    • LINE VOLTAGE TESTING C91956; FDA 3313 - Tests to determine whether a device's insulation has the strength to prevent any current from reaching the operator.
    • OVERCURRENT PROTECTION TESTING C91969; FDA 3324 - Testing the device's over-current protection circuitry for its response to situations of overload, short circuit, or ground fault.
    • POWER SOURCE TESTING C91976; FDA 3329 - Testing the power sources in a device e.g., battery, internal power supply to detect any malfunction.
    • RADIOLOGIC EVALUATION C91983; FDA 3337 - Evaluating the safety provisions in a device used for medical imaging, i.e., if the device can cause injury to individuals during imaging process (visualizing the structure and function of the body).
      • IMAGE ARTIFACT TESTING C91940; FDA 3299 - Testing an imaging device to determine the amount of distortion or signal loss (artifacts) produced in an image.
      • IONIZING RADIATION TESTING C91952; FDA 3310 - Testing that ionizing radiation is delivered at the appropriate energy and dose to the appropriate region of interest for the exam or therapy under evaluation.
      • MAGNETICALLY-INDUCED DISPLACEMENT FORCE TESTING C91957; FDA 3314 - Testing the static magnetic field gradients on medical imaging devices for their ability to move objects.
      • MAGNETICALLY-INDUCED TORQUE TESTING C91958; FDA 3315 - Testing the static magnetic field gradients on medical imaging devices for their ability to rotate objects.
      • RADIOFREQUENCY INDUCED HEAT TESTING C91988; FDA 3341 - Testing the static magnetic field gradients on medical imaging devices for their ability to induce heat in objects.
    • SURGE RESPONSE TESTING C92008; FDA 3357 - Testing for a response to a transient electrical current or voltage.
    • VOLTAGE FLUCTUATION TESTING C92024; FDA 3370 - Testing the device for its immunity when subjected to positive and negative low amplitude voltage fluctuations.
  • ELECTROMAGNETIC COMPATIBILITY (EMC) EVALUATION C91922; FDA 3286 - Evaluating a device to detect malfunctions caused by electromagnetic interference (unwanted disturbances from an external force e.g. radios, cell phones, or unintentional disturbances of another device).
    • EMISSIONS TESTING C91925; FDA 3289 - Testing the device for adequately controlled electromagnetic emissions.
      • CONDUCTED EMISSIONS TESTING C91911; FDA 3276 - Testing the ability of a device's conducted emissions to cause another device to fail (i.e. electromagnetic disturbance for which the energy is transferred via one or more conductors).
      • RADIATED EMISSIONS TESTING C91980; FDA 3333 - Testing the ability of a device's radiated emissions to cause another device to fail (i.e. electromagnetic disturbance for which the energy is transferred through space in the form of electromagnetic waves).
    • IMMUNITY TESTING C91942; FDA 3301 - Testing the device for adequate immunity or capability to resist electromagnetic interference (EMI).
      • ELECTRICAL FAST BURST TESTING C91920; FDA 3284 - Testing the device for failures related to interference voltage tests which are bursts of electrical pulses (e.g. when a switch is turned on or off or the device is plugged in or out).
      • ELECTRICAL SLOW FLUCTUATION TESTING C91921; FDA 3285 - Testing the device to detect malfunctions caused by a sudden reduction of the voltage at a particular point in an electricity supply system below a specified dip threshold followed by its recovery after a brief interval.
      • ELECTROSTATIC DISCHARGE TESTING C91924; FDA 3288 - Testing the device for malfunctions related to the transfer of an electrostatic charge (by direct contact or from electrostatic fields) between objects of different potentials.
      • POWER FREQUENCY MAGNETIC FIELD TESTING C91975; FDA 3328 - Tests performed to verify a device's level of protection (immunity) against magnetic disturbances while operating.
      • RADIOFREQUENCY INTERFERENCE TESTING C91981; FDA 3335 - Testing the device to detect device malfunctions caused by a disturbance affecting an electrical circuit due to electromagnetic radiation emitted from an external source. This includes susceptibility to interference via cables or air.
      • SURGE PROTECTION TESTING C92007; FDA 3356 - Testing the device's ability to protect itself of other devices against sudden bursts of current or voltage.
  • ENVIRONMENT EVALUATION C91926; FDA 3290 - Evaluating devices for responses to physical characteristics in their surroundings.
    • HUMIDITY TESTING C91939; FDA 82 - Testing the device's protective materials to prevent moisture penetration or ingress.
    • LIGHT TESTING C91955; FDA 3312 - Testing the device's characteristics when subjected to variations of ambient light within its surroundings.
    • PRESSURE TESTING C91977; FDA 3330 - Testing the device's characteristics when subjected to high or low pressure conditions.
    • TEMPERATURE TESTING C92010; FDA 3359 - Testing the device's characteristics when subjected to temperature change (cycling), and high or low temperatures.
  • INTEROPERABILITY EVALUATION C91951; FDA 20 - Testing devices for problems with the mechanical, electrical, or communication interface between two or more separate devices or components.
    • DEVICE-TO-DEVICE INTERACTION TESTING C92016; FDA 34 - Tests conducted to assess the mechanical, electrical, or electronic compatibility of two or more devices.
    • DEVICE-TO-HUMAN INTERACTION TESTING C92017; FDA 35 - Tests conducted to assess the interaction between a device and the user.
    • USE TESTING C92020; FDA 3367 - Any testing performed that simulates real use situations experienced by users.
      • IN SITU OBSERVATION C91945; FDA 3304 - Observing the device in the exact same conditions and setting in which the device was used.
      • SIMULATED USE TESTING C91992; FDA 3345 - Testing the devices in situations that mimic real life settings but do not involve patients.
      • USER SURVEY C92021; FDA 3368 - Questioning a pre-defined group of users about their practices.
  • LABELING EVALUATION C91953; FDA 36 - Reviewing all labeling (including instructions for use, manuals, and packaging) for language related to reported device problems.
  • LIGHT SOURCE PERFORMANCE EVALUATION C91954; FDA 3311 - Testing the optical properties of a device such as diopter, glare, and irradiance or glistening.
  • MATERIALS AND CHEMISTRY EVALUATION C91961; FDA 3318 - Testing devices for malfunctions that arise from problems with its components or materials or how its materials or components react to other elements either within the device or within the environment.
    • COMPOSITION TESTING C91909; FDA 3275 - Testing the device to determine if the correct combination of materials or elements is present (e.g., the composition of the materials of a capacitor).
    • DEGRADATION/CORROSION/EROSION TESTING C91916; FDA 3281 - Testing the device for its corrosive behavior to specific environments or materials. Tests may include polarization, potentiostatic, galvanic, critical pitting/crevice temperature, and inhibitor testing.
    • DEVICE STRUCTURE TESTING C92006; FDA 39 - Testing devices for problems related to the presence of an inappropriate molecular geometry somewhere in the device (i.e., the spatial arrangement of atoms in a molecule and the chemical bonds that hold the atoms together).
    • PHYSICAL STRUCTURE TESTING C91973; FDA 3326 - Testing the device for problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials.
    • REACTIVITY TESTING C91984; FDA 3338 - Testing the device for problems related to how the materials react to other factors (e.g. over-react or under-react).
  • MECHANICAL EVALUATION C91963; FDA 26 - Testing the device for problems that result from external forces including fluids, other objects, or environmental or physiologic influences.
    • ACOUSTIC ENERGY TESTING C91898; FDA 3261 - Testing the device for its response to variations in air pressure produced by the vibration of an object.
      • ACOUSTIC NOISE TESTING C91899; FDA 3262 - Testing the device's response to variations in air pressure for detecting any unwanted or unintentional sound.
      • INFRASOUND TESTING C91946; FDA 3305
      • ULTRASONIC SOUND TESTING C92018; FDA 3365 - Testing the devices response to variations in air pressure for detecting sound with frequencies greater than upper limit of human hearing (> 20 kHz).
    • FLOW TESTING C91928; FDA 89 - Testing the device to assess the volume of fluid moving per unit of time. This may also include filter testing.
    • FLUID PRESSURE TESTING C91929; FDA 3292 - Testing the fluid pressure (pressure at some point within a fluid e.g. water or air) within a device.
    • INGRESS PROTECTION TESTING C91947; FDA 3306 - Testing the device's ability to protect against ingress or access of unwanted fluids or solids.
    • STRESS TESTING C92005; FDA 3355 - Testing the device for failures caused by applying force per unit area. This test includes durability testing.
      • COMPRESSION TESTING C91910; FDA 28 - Testing the device for problems that can occur as the result of excessive stress or pressure applied to the device resulting in its compaction (decrease of volume).
      • CREEP (STRENGTH) TESTING C91913; FDA 3278 - Testing the device's ability to withstand a constant tensile load at elevated temperatures. (Creep is the form of plastic deformation that takes place in steel held for long periods at high temperature.)
      • ELASTICITY TESTING C91918; FDA 3283 - Testing the device's ability to recover its size and shape after being deformed during the test.
      • FATIGUE TESTING C91927; FDA 27 - Testing the device's capability to withstand the progressive and localized structural damage that occurs when a material is subjected to cyclic loading. This is a dynamic mechanical test for wear or fatigue.
      • FRACTURE TOUGHNESS TESTING C91930; FDA 3293 - Testing the device's ability to resist local separation into two, or more, pieces under the action of stress.
      • HARDNESS TESTING C91937; FDA 3297 - Testing the device's ability to resist deformation. Hardness is the property of a material that enables it to resist plastic deformation, usually by penetration. However, the term hardness may also refer to resistance to bending, scratching, abrasion or c
      • IMPACT TESTING C91943; FDA 3302 - Testing the device's response to a suddenly applied stress. The test ascertains whether the material is tough or brittle.
      • SHOCK TESTING C91991; FDA 3344 - Examining a device for problems resulting from transient physical insults such as dropping or shaking the device.
      • STRENGTH TESTING C92004; FDA 3354 - Testing the device's ability to resist forces that attempt to break or deform the device. This evaluation includes testing tension such as pull testing.
      • VIBRATION TESTING C92022; FDA 3369 - Evaluating a device for problems resulting from periodic or random mechanical oscillations which could induce damage.
      • WEAR TESTING C92025; FDA 3371 - Examining a device for signs of unexpected erosion on its surface or other components or parts.
  • PROCESS EVALUATION C91978; FDA 3331 - Performing a review of the manufacturing and production processes and/or records for a specific device or lot that may have contributed to problems with a device.
    • ASSEMBLY AND PACKAGING REVIEW C91902; FDA 3266 - Performing a review of the assembly and packaging processes and records for a specific device or lot that may have contributed to problems with the device.
    • INSTALLATION REVIEW C91948; FDA 3307 - Performing a review of the processes used to install a device and the records reflecting these processes performed for a specific device.
    • MAINTENANCE REVIEW C91959; FDA 3316 - 'Performing a review the technical and corresponding administrative actions and records intended to retain an item in, or restore it to, a state in which it can perform its required function. This evaluation includes reviewing the user's maintenance procedures and processes as to whether they were followed.
    • MANUFACTURING REVIEW C91960; FDA 3317 - Performing a review of the manufacturing steps and processes to ensure that they were met and followed and that the device records reflected these processes.
    • QUALITY CONTROL REVIEW C91979; FDA 3332 - Performing a review of the processes used in developing systems to ensure that products are designed and produced and services are developed to meet or exceed device specifications and customer expectations.
    • STERILIZATION PROCESS REVIEW C92002; FDA 3352 - Performing a review of the records and processes used to render a product free from viable microorganisms.
      • PACKAGING VERIFICATION C91970; FDA 3325 - Verifying that the device packaging met proper sterilization conditions and that the effectiveness of the packaging kept the device free viable microorganisms.
      • STERILITY METHOD VERIFICATION C92001; FDA 3351 - Verifying that the methods used to free a medical device from viable microorganisms such as fungi, bacteria, and viruses were followed.
    • STORAGE AND SHIPMENT REVIEW C92003; FDA 3353 - Performing a review of the storage and shipping processes and requirements.
  • SOFTWARE EVALUATION C91993; FDA 22
    • ANALYSIS OF DATA LOG(S) C102867; FDA 3372 - Analysis of device log data such as error or keystroke log, or device alarm history.
    • CODE REVIEW C91997; FDA 3273 - A systematic review of source code intended to find and fix mistakes possibly overlooked in the initial development phase.
    • SOFTWARE VALIDATION C91995; FDA 3347 - Validating that a system or component during or at the end of the development process satisfies specified requirements (the process may include algorithm evaluation).
      • CODE VALIDATION C91998; FDA 3272 - Ensuring that common error patterns and violations of best practices in coding have been followed.
      • DATA VALIDATION C91915; FDA 3280 - Ensuring that data used and generated by a program is correct.
      • DESIGN VALIDATION C91917; FDA 3282 - Validating that the device meets the user's needs and intended uses.
    • SOFTWARE VERIFICATION C91996; FDA 3348 - A process used to verify that a system or component performs according to the original set of conditions at any point in development.
      • SOFTWARE STRESS TESTING C91994; FDA 3346 - Tests conducted to evaluate a software application at or beyond the limits of its specified requirements.
      • STATIC ANALYSIS C92000; FDA 3350 - The process of analyzing the software code without running it. For example, formal verification, which is proving or disproving the correctness of intended algorithms underlying a system with respect to a certain formal specification or property using formal methods of mathematics e.g. model checking, theorem proving, symbolic verification).
      • SYSTEM TESTING C92009; FDA 3358 - Tests conducted on a complete, integrated system to evaluate the system's compliance with its specified requirements.
      • UNIT TESTING C92019; FDA 3366 - Testing of individual hardware or software components or groups of related units.
  • THERMAL ENERGY EVALUATION C92013; FDA 3362 - Testing the device for conditions related to extremes of temperature.
    • TEST FOR HIGH TEMPERATURE CONDITIONS C92011; FDA 3360
    • TEST FOR LOW TEMPERATURE CONDITIONS C92012; FDA 3361
  • VISUAL INSPECTION C92023; FDA 38
    • IMAGE INSPECTION C91941; FDA 3300 - Macroscopic inspection commonly used to describe physical objects that are measurable and observable by the naked eye.
      • PHOTOGRAPHIC INSPECTION C91972; FDA 37
      • RADIOGRAPHIC INSPECTION C91982; FDA 3336
        • GRADIENT-INDUCED FIELD EFFECT TESTING C91935; FDA 3295 - Testing the RF shield around the coils of an MRI device for its ability to provide effective screening against electrical (eddy) currents induced by gradient switching.
    • MICROSCOPIC INSPECTION C91965; FDA 3321 - Inspection of objects or surfaces requiring magnification using a microscope e.g. with electron, optical, or scanning probe microscopy.
      • ELECTRON MICROSCOPY C91923; FDA 3287 - Inspection of objects or surfaces requiring magnification using an electron microscope.
      • OPTICAL MICROSCOPY C91968; FDA 84 - Inspection of objects or surfaces requiring magnification using an optical microscope.
      • SCANNING PROBE MICROSCOPY C91990; FDA 3343 - Inspection of objects or surfaces requiring magnification using a scanning probe microscope.
    • SPECTROSCOPY C91999; FDA 3349 - Testing the device using a spectrometer or spectrograph for the dispersion of visible light (includes electromagnetic, electron, and acoustic spectroscopy).