Glossary

injury or damage to the health of people, or damage to property or the environment

[ISO 14971:2019]

potential source of harm

[ISO 14971:2019]

Note: Basic hazards are directly associated with functional outputs.  Extended hazards are directly associated with extended functional outputs (i.e., indirectly associated with functional outputs).

a systematic approach to identify hazards and hazardous situations and to control and monitor the associated risks by focusing on the critical control points in a manufacturing process

[ISO/TR 24971:2020]

table for documenting the causes of hazards and exposure to hazards and the corresponding risk control measures

circumstance in which people, property or the environment is/are exposed to one or more hazards

[ISO 14971:2019]

a physician or other individual who is a health care provider and licensed under state law to prescribe drugs or devices

[FDA 21CFR99]

medical device, including in vitro diagnostic medical device, or medicinal product, including biopharmaceutical

[ISO 11139:2018]

medical device; drug; biologic product; human cell, tissue, and cellular and tissue-based product (HCT/P); or a combination product

practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical therapists, technologists, or any other practitioners or allied health professionals that have a role in using a device for human use

[FDA 21CFR810]

practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical therapists, technologists, or any other practitioners or allied health professionals that have a role in using a device for human use

[FDA 21CFR810]

medical device risk management that focuses on harm and safety as defined by ISO 14971

medical device risk management that focuses on harm and safety as defined by ISO 14971

HCT/Ps refers to human cell, tissue, and cellular and tissue-based products, as defined in §1271.3(d) of this chapter. An HCT/P that is not solely regulated under section 361 of the Public Health Service Act may be a constituent part of a combination product. Such an HCT/P is subject to part 1271 of this chapter and is also regulated as a drug, device, and/or biological product.

[FDA 21CFR4]

an HCT/P as defined in 1271.3(d) of this chapter that does not meet the criteria in 1271.10(a) and that is also regulated as a device

[FDA 21CFR801, FDA 21CFR803, FDA 21CFR806, FDA 21CFR810, FDA 21CFR814, FDA 21CFR820, FDA 21CFR821, FDA 21CFR822, FDA 21CFR830]

an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.  A subject may be either a healthy human or a patient.

[FDA 21CFR50, FDA 21CFR56]

a premarket approval application submitted pursuant to this subpart seeking a humanitarian device exemption from the effectiveness requirements of sections 514 and 515 of the act as authorized by section 520(m)(2) of the act

[FDA 21CFR814]

Note: An HDE is a marketing application for an HUD.

a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year

[FDA 21CFR814]