Statements (20)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
medical devices
non-significant risk devices significant risk devices |
| gptkbp:citation |
gptkb:21_CFR_Part_812
|
| gptkbp:establishes |
requirements for clinical investigations of medical devices
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR 812
|
| gptkbp:includes |
labeling requirements
reporting requirements requirements for informed consent records maintenance requirements for Institutional Review Board approval |
| gptkbp:partOf |
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
| gptkbp:purpose |
to allow investigational devices to be used in clinical studies
|
| gptkbp:regulates |
gptkb:Investigational_Device_Exemptions
|
| gptkbp:requires |
IDE application
|
| gptkbp:startDate |
gptkb:United_States
|
| gptkbp:bfsParent |
gptkb:FDA_investigational_device_exemption_(2023)
|
| gptkbp:bfsLayer |
7
|