Premarket Approval (PMA) in US

URI: https://gptkb.org/entity/Premarket_Approval_(PMA)_in_US
GPTKB entity
Statements (26)
Predicate Object
gptkbp:instanceOf gptkb:medical_device_regulatory_process
gptkbp:alternativeTo 510(k) clearance
gptkbp:application gptkb:medical_device_manufacturer
gptkbp:appliesTo Class III medical devices
gptkbp:approvalNeededBefore marketing device in US
gptkbp:canBeSupplements PMA supplement
gptkbp:establishedIn 1976
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 8
https://www.w3.org/2000/01/rdf-schema#label Premarket Approval (PMA) in US