An FDA 510 (k) is the technical documentation required for those intending to market a medical device in the US, where a premarket approval application (PMA) is not required. 510(k)’s are predominantly for Class II medical devices (although also some Class I, and Class III medical devices) that are intended for human use. The 510 (k) premarket submission demonstrates a medical devices safety and effectiveness for use.
For those not experienced in submitting an FDA 510(k), the process can be overwhelming as it requires the submission of lengthy documents, sometimes upwards of 100 pages, requiring precise detail on your medical device and the relevant safety procedures taken. In the submission you will need to detail the similarities and differences of your medical device with a similar device that already exists on the market. The comparable device is known as a predicate device, and it is up to you to demonstrate substantial equivalence. This details the likeness of your device and the predicate device.
Involved in the 510(k) documentation, is the detailing of all necessary testing methods and results that have been performed on your product, in line with the predicate device and any additional observed testing requirements. It is important you are exhaustive in your testing of the device, as the FDA will require a product to re-submit the 510(k) premarket notification if you do not meet satisfactory detail, or your premarket approval timeframe expands past the 90-day review limit.
