What is 510(k)?

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.

1. Domestic manufacturers introducing a device to the U.S. market.
2. Specification developers introducing a device to the U.S. market.
3. Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
4. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.

* 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:

1. Introducing a device into commercial distribution (marketing) for the first time (unless exempt).
2. There is a change or modification to a legally marketed device that could significantly affect its safety or effectiveness.

* Source: https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k