Glossary > 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 |
