Medical Device User Fee Amendments
GPTKB entity
Statements (22)
| 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
medical device importers |
| gptkbp:approvedBy |
2007
2012 2017 2022 |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:dateEnacted |
2002
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| https://www.w3.org/2000/01/rdf-schema#label |
Medical Device User Fee Amendments
|
| gptkbp:partOf |
gptkb:Medical_Device_User_Fee_and_Modernization_Act
|
| gptkbp:purpose |
authorize FDA to collect user fees from medical device manufacturers
|
| gptkbp:regulates |
medical device establishment registration
medical device inspections medical device premarket submissions |
| gptkbp:relatedTo |
gptkb:FDA_Safety_and_Innovation_Act
gptkb:Prescription_Drug_User_Fee_Act |
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration_Safety_and_Innovation_Act
|
| gptkbp:bfsLayer |
6
|