510(k) premarket notification for medical devices
GPTKB entity
Statements (31)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:alsoKnownAs |
510(k) submission
Premarket Notification |
| gptkbp:alternativeTo |
Premarket Approval (PMA)
|
| gptkbp:application |
importer
medical device manufacturer specification developer |
| gptkbp:appliesTo |
medical devices
|
| gptkbp:compatibleWith |
Class III medical devices
most Class I medical devices |
| https://www.w3.org/2000/01/rdf-schema#label |
510(k) premarket notification for medical devices
|
| gptkbp:introducedIn |
1976
|
| gptkbp:legalBasis |
Section 510(k) of the Food, Drug, and Cosmetic Act
|
| gptkbp:purpose |
demonstrate substantial equivalence to legally marketed device
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
Class II medical devices
some Class I medical devices |
| gptkbp:result |
FDA clearance
clearance to market device in U.S. |
| gptkbp:reviewTime |
typically 90 days
|
| gptkbp:submissionFee |
required
|
| gptkbp:submissionIncludes |
labeling
performance data device description intended use proposed indications for use substantial equivalence comparison |
| gptkbp:website |
https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
|
| gptkbp:YouTubeChannel |
gptkb:FDA_Center_for_Devices_and_Radiological_Health
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|