An FDA 510(k) is the technical dossier that must be submitted to the US Food and Drug Administration (FDA) for devices meant to be used on humans. The 510(k) application is made to the FDA by a medical device manufacturer or a specification developer to demonstrate that the device to be marketed is as safe and effective, substantially equivalent, to a legally marketed device in the USA.
The 510(k) documentation must include a description of the medical device, models, and accessories or components that come in direct contact with patients, as well as device performance specifications. Once FDA determines the submitted device is substantially equivalent, a 510(k) number is granted, or in other words, 510(k) approval is granted. It is not to be called an FDA 510k Certification.
The 510(k) submission is also known as a Pre-market Notification. This includes technical, performance, and safety information about the medical device. A 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 who wish to market their medium-risk medical device or IVD in the U.S. The 510(k) submission is also known as a Pre-market Notification.
The regulatory documentation submitted as part of 510(k) should be able to demonstrate the proposed device is at least as safe and effective as a legally marketed device in the U.S.A Legally marketed device is a medical device that has already received 510k clearance for sale in the U.S. To prove substantial equivalence, the similarities and differences between the proposed device and predicate device will have to be compared, and suitable laboratory testing must be performed. Human testing is not generally needed as part of FDA 510(k) submissions. Submissions are generally required for most Class II medical devices, Class I and Class III devices, and IVDs.
Generally, there is three types of 510k’s: (1) Abbreviated 510k (2) Traditional 510k (3) Special 510k. More details can be found in the article section below.