Statements (35)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:alternativeTo |
Premarket Approval (PMA)
|
| gptkbp:applicableLaw |
21 CFR 807 Subpart E
|
| gptkbp:application |
medical device manufacturers
|
| gptkbp:appliesTo |
domestic and foreign manufacturers
|
| gptkbp:compatibleWith |
Class III medical devices
most Class I medical devices devices exempted by regulation |
| gptkbp:doesNotImply |
FDA approval
|
| https://www.w3.org/2000/01/rdf-schema#label |
510(k) clearance in US
|
| gptkbp:introducedIn |
1976
|
| gptkbp:legalBasis |
Section 510(k) of the Food, Drug, and Cosmetic Act
|
| gptkbp:namedAfter |
Section 510(k) of the FD&C Act
|
| gptkbp:predicateDevice |
legally marketed device (substantially equivalent)
|
| gptkbp:purpose |
demonstrate substantial equivalence to a legally marketed device
|
| gptkbp:regulates |
medical devices
|
| gptkbp:requires |
Class II medical devices
some Class I medical devices marketing device in US |
| gptkbp:result |
FDA clearance letter
clearance to market device in US |
| gptkbp:reviewedBy |
gptkb:FDA_Center_for_Devices_and_Radiological_Health
|
| gptkbp:reviewTime |
typically 90 days
|
| gptkbp:submissionIncludes |
labeling
performance data device description intended use proposed indications for use substantial equivalence comparison predicate device information |
| gptkbp:website |
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/510k-clearances
|
| gptkbp:YouTubeChannel |
premarket notification
|
| gptkbp:bfsParent |
gptkb:Medical_Device_Regulation
|
| gptkbp:bfsLayer |
7
|