Premarket Approval (PMA) in US
GPTKB entity
Statements (26)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
medical device regulatory process
|
| gptkbp:alternativeTo |
510(k) clearance
|
| gptkbp:application |
medical device manufacturer
|
| gptkbp:appliesTo |
Class III medical devices
|
| gptkbp:approvalNeededBefore |
marketing device in US
|
| gptkbp:canBeSupplements |
PMA supplement
|
| gptkbp:establishedIn |
1976
|
| https://www.w3.org/2000/01/rdf-schema#label |
Premarket Approval (PMA) in US
|
| gptkbp:includes |
clinical studies
preclinical studies manufacturing information device labeling |
| gptkbp:legalBasis |
gptkb:Medical_Device_Amendments_of_1976
|
| gptkbp:postApprovalRequirement |
annual reports
post-approval studies |
| gptkbp:purpose |
demonstrate safety and effectiveness
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
clinical data
scientific evidence high-risk medical devices |
| gptkbp:result |
approval or denial
|
| gptkbp:reviewedBy |
gptkb:FDA_Center_for_Devices_and_Radiological_Health
|
| gptkbp:website |
https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma
|
| gptkbp:YouTubeChannel |
premarket submission
|
| gptkbp:bfsParent |
gptkb:Medical_Device_Regulation
|
| gptkbp:bfsLayer |
7
|