Glossary

a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also “implants” for purposes of this part.

[FDA 21CFR812]

a device that is intended to be placed in a surgically or naturally formed cavity of the human body. A device is regarded as an implantable device for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner of Food and Drugs determines otherwise in order to protect human health

[FDA 21CFR801]

any device, including those that are partially or wholly absorbed, which is intended:
— to be totally introduced into the human body, or
— to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure

Note: Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device

[EU MDR 2017/745]

medical device which can only be removed by medical or surgical intervention and which is intended to
- be totally or partially introduced into the human body or a natural orifice, or
- replace an epithelial surface or the surface of the eye, and
- remain after the procedure for at least 30 days

Note: This definition of implantable medical device includes active implantable medical device

[ISO 13485:2016]

any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
(a) concerning a physiological or pathological process or state;
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a disease;
(d) to determine the safety and compatibility with potential recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures.

Note: Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices

[EU IVDR 2017/746]

medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring, or compatibility purposes

Note: IVD medical devices include reagents, calibrators, control materials, specimen receptacles, software and related instruments or apparatus or other articles and are used, for example, for the following test purposes: diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, determination of physiological status.

[ISO 20916:2019]

those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.

[FDA 21CFR809]

any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect

[EU MDR 2017/745]

any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device

[EU IVDR 2017/746]

a qualified person who does not have direct responsibility for the design work being reviewed that participates in the design review and provides oversight for design control content

a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.

[FDA 21CFR814, FDA guidance: Deciding When to Submit...(2014)]

Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.

[FDA website: Who Must Register...]

determination of conformity to specified requirements

Note 1: If the result of an inspection shows conformity, it can be used for purposes of verification.
Note 2: The result of an inspection can show conformity or nonconformity or a degree of conformity.

[ISO 9000:2015]

process of combining various inputs to verify that the product meets its product design specifications

measures that ensure that the medical device is installed at the customer location such that product design specifications are met with identification and traceability maintained

process of combining various inputs in order to install a medical device such that the medical device is ready for use

any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act.

[FDA 21CFR56]

any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act.

[FDA 21CFR50]

any board, committee, or other group formally designated by an institution to review biomedical research involving subjects and established, operated, and functioning in conformance with part 56. The term has the same meaning as “institutional review committee” in section 520(g) of the act.

[FDA 21CFR812]

the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken

[EU MDR 2017/745, EU IVDR 2017/746]

the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken

[EU MDR 2017/745, EU IVDR 2017/746]

those parts of accompanying documents giving the necessary information for safe and proper use and operation of the equipment

[IEC TR 60788:2004]

the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation

[EU MDR 2017/745]

the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation

[EU IVDR 2017/746]

the general purpose of the device or its function. The intended use of a device encompasses the indications for use.

[FDA guidance: The 510(k) Program...(2014), FDA guidance: Deciding When to Submit...(2014)]

objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the IVD manufacturer

Note: Intended use statements for IVD labelling can include two components: a description of the functionality of the IVD medical device (e.g. an immunochemical measurement procedure for the detection of analyte “x” in serum or plasma), and a statement of the intended medical use of the examination results.

[ISO 20916:2019]

use for which a product, process, or service is intended according to the specifications, instructions and information provided by the manufacturer

Note 1: The intended medical indication, patient population, part of the body or type of tissue interacted with, user profile, use environment, and operating principle are typical elements of the intended use.

[ISO 14971:2019]

Note 2: Intended use should not be confused with normal use. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, transport, etc. as well.

[IEC 60601-1:2012]

the words intended uses or words of similar import in §§801.5, 801.119, and 801.122 refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.

Note: The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the devices, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

[FDA 21CFR801]

a device, including a transitional device, that is the object of an investigation

[FDA 21CFR812]

a device that is assessed in a clinical investigation

[EU MDR 2017/745]

an approved or considered approved investigational device exemption under section 520(g) of the act and parts 812 and 813

[FDA 21CFR814]

medical device being assessed for clinical performance, effectiveness, or safety in a clinical investigation

Note 1: This includes medical devices already on the market that are being evaluated for new intended uses, new populations, new materials or design changes.
Note 2: This includes medical devices already on the market that are being evaluated within their intended use in a post-market clinical investigation (interventional or non-interventional).
Note 3: For the purpose of this document, the terms “investigational medical device” and “investigational device” are used interchangeably.

[ISO 14155:2020]

any part, component, device, subsystem, functional unit, equipment or system that can be individually considered

[IEC 60812:2006]