Investigational Device Exemptions
GPTKB entity
Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:abbreviation |
gptkb:IDE
|
| gptkbp:allows |
use of unapproved medical devices in clinical trials
|
| gptkbp:appliesTo |
medical devices
|
| gptkbp:compatibleWith |
non-significant risk device studies
|
| gptkbp:country |
gptkb:United_States
|
| https://www.w3.org/2000/01/rdf-schema#label |
Investigational Device Exemptions
|
| gptkbp:legalBasis |
gptkb:21_CFR_812
|
| gptkbp:purpose |
allow investigational devices to be used in clinical studies
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
premarket approval
medical device clinical investigation |
| gptkbp:requires |
Institutional Review Board approval
significant risk device studies submission to FDA |
| gptkbp:bfsParent |
gptkb:21_CFR_812
|
| gptkbp:bfsLayer |
8
|