Section 510(k) (Premarket Notification)
GPTKB entity
Statements (38)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
FDA regulatory process
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:alternativeTo |
Premarket Approval (PMA)
|
| gptkbp:application |
device manufacturer
specification developer device distributor |
| gptkbp:appliesTo |
medical devices
Class II medical devices Class I medical devices |
| gptkbp:chronology |
typically 90 days review
|
| gptkbp:clearanceMeans |
device is substantially equivalent to predicate device
|
| gptkbp:compatibleWith |
devices exempt from 510(k) requirements
most Class III medical devices |
| https://www.w3.org/2000/01/rdf-schema#label |
Section 510(k) (Premarket Notification)
|
| gptkbp:introducedIn |
1976
|
| gptkbp:legalBasis |
Section 510(k) of the Federal Food, Drug, and Cosmetic Act
|
| gptkbp:predicateDevice |
legally marketed device
|
| gptkbp:purpose |
demonstrate substantial equivalence to a legally marketed device
|
| gptkbp:regulates |
introduction of new medical devices to U.S. market
|
| gptkbp:regulatoryGoal |
ensure safety and effectiveness of medical devices
|
| gptkbp:relatedTo |
Premarket Approval (PMA)
De Novo classification Investigational Device Exemption (IDE) |
| gptkbp:requires |
marketing new medical devices in the U.S.
|
| gptkbp:result |
clearance to market device
|
| gptkbp:reviewedBy |
gptkb:FDA_Center_for_Devices_and_Radiological_Health
|
| gptkbp:statutoryReference |
21 CFR 807 Subpart E
|
| gptkbp:submissionFee |
required
|
| gptkbp:submissionIncludes |
labeling
performance data device description intended use substantial equivalence comparison safety and effectiveness information |
| gptkbp:website |
https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
|
| gptkbp:YouTubeChannel |
premarket notification
|
| gptkbp:bfsParent |
gptkb:FD&C_Act
|
| gptkbp:bfsLayer |
7
|