A 510k is a premarket submission made to FDA that demonstrates the device to be sold is as safe and effective, that is, substantially equivalent, to a legally marketed device. A technical file know as 510(k) needs to be submitted to the FDA for devices meant to be used on humans.
A 510(k) submission must be made for devices, which do not need a Premarket approval (PMA) and are not exempt from the 510(k) requirements, by manufacturers of medium-risk medical devices or IVD, who wish to market their devices in the U.S. The 510(k) submission or premarket submission includes technical, performance and safety information about the medical device.
A 510k is required for introducing most Class II medical devices, some Class I and Class III devices and IVDs in the U.S. market, a 510(k) submission needs to be made by:
- A U.S. manufacturer wish to introduce a finished medical device.
- A specification manufacturer who develops the specifications for a device but manufactures the device under contract with another firm wish to introduce the device.
- Re-packagers and re-labelers if significant change is made in the labeling or if the condition of the device is affected.
- Foreign manufacturers or exporters
The Premarket approval (PMA) is the regulatory pathway chosen for class III devices which are used to sustain/ support the human life and present substantial risks. This method is used to prove the safety and performance of a new medical device using data obtained from laboratory testing and clinical trials with human participants in most cases.