FDA (for investigational use)
GPTKB entity
Statements (13)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory designation
|
| gptkbp:appliesTo |
medical products
|
| gptkbp:awardedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:doesNotPermit |
commercial distribution
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA (for investigational use)
|
| gptkbp:not_equivalent_to |
FDA approval
|
| gptkbp:permits |
use in human subjects under controlled conditions
|
| gptkbp:purpose |
allow use of unapproved medical products in clinical trials
|
| gptkbp:regulates |
clinical research
|
| gptkbp:requires |
investigational device exemption applications
investigational new drug applications |
| gptkbp:bfsParent |
gptkb:Jarvik-7
|
| gptkbp:bfsLayer |
7
|