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10/21/2014Premarket Notification (510k) Content of a 510(k)Home Medical Devices Device Advice: Comprehensive Regulatory Assistance How to Market Your Device Premarket Submissions Premarket Notification
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What is premarket notification 510k content?
The premarket notification 510k content is a submission to the FDA that demonstrates a medical device is substantially equivalent to a device already on the market.
Who is required to file premarket notification 510k content?
Manufacturers of medical devices that are not exempt from premarket notification requirements are required to file premarket notification 510k content.
How to fill out premarket notification 510k content?
To fill out premarket notification 510k content, manufacturers need to provide information about the device, its intended use, its technological characteristics, and demonstrate its substantial equivalence to a predicate device.
What is the purpose of premarket notification 510k content?
The purpose of premarket notification 510k content is to demonstrate that a new medical device is as safe and effective as a legally marketed device, known as a predicate device.
What information must be reported on premarket notification 510k content?
Information such as device description, intended use, technological characteristics, performance data, and comparison to predicate devices must be reported on premarket notification 510k content.
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