FDA investigational device exemption (2023)
GPTKB entity
Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:application |
promoter
IDE application device manufacturer |
| gptkbp:appliesTo |
medical devices
|
| gptkbp:enables |
collection of safety and effectiveness data
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA investigational device exemption (2023)
|
| gptkbp:permits |
shipment of unapproved devices for clinical investigation
|
| gptkbp:purpose |
allow investigational device use in clinical studies
|
| gptkbp:regulates |
gptkb:21_CFR_812
|
| gptkbp:relatedTo |
clinical trials
premarket approval process |
| gptkbp:requires |
devices not yet approved for marketing
|
| gptkbp:reviewedBy |
gptkb:FDA_Center_for_Devices_and_Radiological_Health
|
| gptkbp:year |
2023
|
| gptkbp:bfsParent |
gptkb:Link_(neural_implant)
|
| gptkbp:bfsLayer |
6
|