Expedited Access Pathway (EAP)
GPTKB entity
Statements (14)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
FDA regulatory program
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:announced |
2015
|
| gptkbp:appliesTo |
510(k) submissions
de novo requests premarket approval (PMA) |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:focusesOn |
breakthrough medical devices
|
| gptkbp:goal |
to provide patients with more timely access to medical devices
|
| https://www.w3.org/2000/01/rdf-schema#label |
Expedited Access Pathway (EAP)
|
| gptkbp:purpose |
to speed development and review of certain medical devices
|
| gptkbp:replacedBy |
Breakthrough Devices Program
|
| gptkbp:bfsParent |
gptkb:FDA_Breakthrough_Device_designation
|
| gptkbp:bfsLayer |
8
|