Medical Device User Fee Amendments (MDUFA)
GPTKB entity
Statements (20)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:abbreviation |
gptkb:MDUFA
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
medical device manufacturers
|
| gptkbp:approvedBy |
2007
2012 2017 2022 |
| gptkbp:category |
Healthcare regulation
|
| gptkbp:country |
gptkb:United_States
|
| gptkbp:dateEnacted |
2002
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| gptkbp:goal |
improve timeliness of FDA review
|
| https://www.w3.org/2000/01/rdf-schema#label |
Medical Device User Fee Amendments (MDUFA)
|
| gptkbp:partOf |
Medical Device User Fee and Modernization Act (MDUFMA)
|
| gptkbp:purpose |
fund FDA review of medical devices
|
| gptkbp:relatedTo |
gptkb:Prescription_Drug_User_Fee_Act_(PDUFA)
|
| gptkbp:requires |
user fees for device submissions
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|