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Glossary

Expected Life of a Device

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The time that a device is expected to remain functional after it is placed into use. 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. 

Other glossary definitions

A

Applicant for Clinical Trial Applications (CTA)

An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees. Applicant…

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U

Unanticipated Adverse Device Effect (UADE)

Any serious adverse effect on health or safety or any life-threatening problem or death caused…

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