Glossary:TAG-00261-Una-ner

Glossary > Unanticipated device effect

Unanticipated device effect
Tag-ID	TAG-00261-Una-ner
English	Unanticipated adverse device effect / Unanticipated serious adverse device effect
EN Abbr.	UADE / USADE
French	Effet indésirable grave inattendu d'un dispositif médical / Effet indésirable grave inattendu et imprévu
FR Abbr.	UADE / USADE
German	Unerwarteter schwerwiegender Gerätezwischenfall / Unerwartete schwerwiegende unerwünschte Gerätewirkung
DE Abbr.	UADE / USADE

References

	Scope	Document part	Language	Document
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51	MD	3.51	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (1)	MD	§ 812.150 (a) (1)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (4)	MD	§ 812.150 (a) (4)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1)	MD	§ 812.150 (b) (1)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s)	MD	§ 812.3 (s)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b)	MD	§ 812.46 (b)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001	MD	§ 812.46 (b) - (c)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-002	MD	§ 812.46 (b) - (c)	EN	USA 21 CFR Part 812 09-Apr-2025
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV.	G	III A. ; IV.	EN	USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation	G	Introduction ; III. B. ; Evaluation	EN	USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV.	G	Introduction ; III. B. ; IV.	EN	USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009