Premarket Approval (PMA) for medical devices
GPTKB entity
Statements (29)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:alternativeTo |
510(k) clearance
|
| gptkbp:appliesTo |
gptkb:United_States
Class III medical devices |
| gptkbp:approvedBy |
market entry of Class III devices in the U.S.
|
| gptkbp:cause |
PMA approvable letter
PMA denial PMA not approvable letter |
| gptkbp:establishedBy |
Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act
|
| gptkbp:establishedIn |
1976
|
| https://www.w3.org/2000/01/rdf-schema#label |
Premarket Approval (PMA) for medical devices
|
| gptkbp:openToPublic |
PMA summaries
|
| gptkbp:purpose |
ensure safety and effectiveness
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
clinical data
scientific evidence |
| gptkbp:result |
PMA approval order
|
| gptkbp:reviewedBy |
gptkb:FDA_Center_for_Devices_and_Radiological_Health
|
| gptkbp:subject |
postmarket surveillance
annual reporting post-approval requirements |
| gptkbp:submissionIncludes |
labeling
clinical studies preclinical studies manufacturing information device description proposed indications for use |
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|