Glossary
Selected key terms pertaining to medical device development are listed below with References.
Key Terms
There are currently 9 key terms in this directory beginning with the letter E.
effective
There is reasonable assurance that a device is effective when it can be determined, based upon valid scientific evidence, that in a significant portion of the target population, the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will provide clinically significant results.
[FDA 21CFR860]
effectiveness
extent to which planned activities are realized and planned results are achieved
[ISO 9000:2015]
emergency use
the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval
[FDA 21CFR56]
essential output (EO)
product design output that is essential for the proper functioning of the medical device
expected life of a device
the time that a device is expected to remain functional after it is placed into use
Note: Certain implanted devices have specified “end of life” (EOL) dates. Other devices are not labeled as to their respective EOL, but are expected to remain operational through activities such as maintenance, repairs, or upgrades, for an estimated period of time.
Note: Certain implanted devices have specified “end of life” (EOL) dates. Other devices are not labeled as to their respective EOL, but are expected to remain operational through activities such as maintenance, repairs, or upgrades, for an estimated period of time.
[FDA 21CFR803]
expected service life
time period specified by the manufacturer during which the medical device is expected to remain safe for use (i.e. maintain basic safety and essential performance)
Note: Maintenance can be necessary during the expected service life.
Note: Maintenance can be necessary during the expected service life.
[IEC 62366-1:2015]
expenses
the cost of operations that a company incurs to generate revenue.
Note: Common expenses include payments to suppliers, employee wages, factory leases, and equipment depreciation.
Note: Common expenses include payments to suppliers, employee wages, factory leases, and equipment depreciation.
[Investopedia]
expert
a person competent on the basis of appropriate education, training, skills and experience
[ISO/TR 24971:2020]
Medical device developers are strongly encouraged to consult the listed reference for each key term to fully understand the context behind the definition and its intended application.
Definitions from the FDA Code of Federal Regulation (CFR) are listed without dates and are accurate through December 2020. Consult the listed FDA reference (online) to confirm the latest definition.