510(k) refers to section 510(k) of the Federal Food, Drug and Cosmetic Act.
* Source: https://www.fda.gov/training-and-continuing-education/cdrh-learn/510k-program-transcript
The Federal Food, Drug and Cosmetic Act does not specify who must submit a 510(k), but rather, which actions require a 510(k) submission.
* Source: https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
A device is considered substantially equivalent if, in comparison to a predicate, it has the same intended use and technological characteristics as the predicate or if it has the same intended use as the predicate and has different technological characteristics and does not raise different questions of safety and effectiveness and the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.
* Source: https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
A 510(k) is required when:
* Source: https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
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