|
gptkbp:instanceOf
|
gptkb:United_States_federal_law
|
|
gptkbp:administeredBy
|
gptkb:U.S._Food_and_Drug_Administration
|
|
gptkbp:appliesTo
|
investigational medical devices
|
|
gptkbp:citation
|
gptkb:21_U.S.C._360j(g)
|
|
gptkbp:covers
|
significant risk devices
nonsignificant risk devices
|
|
gptkbp:enforcedBy
|
gptkb:FDA_Center_for_Devices_and_Radiological_Health
|
|
gptkbp:establishes
|
requirements for Institutional Review Boards
requirements for investigators
requirements for sponsors
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
21 CFR Part 812
|
|
gptkbp:partOf
|
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
|
gptkbp:purpose
|
to allow the use of unapproved medical devices in clinical studies
|
|
gptkbp:regulates
|
clinical investigations of medical devices
|
|
gptkbp:requires
|
IRB approval
Investigational Device Exemption (IDE)
informed consent from study subjects
monitoring of investigations
reporting of adverse events
|
|
gptkbp:startDate
|
1976
|
|
gptkbp:title
|
gptkb:Investigational_Device_Exemptions
|
|
gptkbp:bfsParent
|
gptkb:21_CFR_812
|
|
gptkbp:bfsLayer
|
8
|