Unanticipated serious adverse device effect (USADE)

Whether a SADE is anticipated depends on what the reference safety information, such as the investigator's brochure or risk analysis, already describes. A USADE can signal a new risk and may lead to changes in the study or the device.

serious adverse device effect (3.44) which by its nature, incidence, severity or outcome has not been identified in the current risk assessment Note 1 to entry: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or outcome has been identified in the risk assessment.

ISO 14155:2020, clause 3.51

Any SADE, the nature, severity or outcome of which is not consistent with the reference safety information. See ISO 20916 section 3.52.

MDCG 2024-4, Section 4.23

Any serious adverse device effect, the nature, severity or outcome of which is not consistent with the reference safety information.

MDCG 2020-10/1 Rev.1, Section 3.11