The 510k submission in the USA can be used to obtain approval to market a medical device within the USA. It basically requires that the device concerned is similar to a device which has been approved for marketing by the FDA. Once a predicate device has been identified device has been identified a dossier is prepared demonstrating that the device is similar to an existing device. If this dossier is found to be acceptable to the FDA, approval to market a new device can be obtained within 90 days.
