FDA Breakthrough Device designation
GPTKB entity
Statements (21)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory designation
|
| gptkbp:appliesTo |
medical devices
|
| gptkbp:awardedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:benefit |
priority review
access to senior FDA managers collaborative and efficient review process interactive communication with FDA |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:criteria |
device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases
device offers significant advantages over existing alternatives device represents breakthrough technology no approved or cleared alternatives exist device availability is in the best interest of patients |
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Breakthrough Device designation
|
| gptkbp:introducedIn |
2016
|
| gptkbp:legalBasis |
gptkb:21st_Century_Cures_Act
|
| gptkbp:purpose |
expedite development and review of medical devices
|
| gptkbp:relatedTo |
gptkb:FDA_Breakthrough_Therapy_designation
|
| gptkbp:replacedBy |
gptkb:Expedited_Access_Pathway_(EAP)
|
| gptkbp:bfsParent |
gptkb:Stentrode
|
| gptkbp:bfsLayer |
7
|