Premarket notification, also known as 510(k) notification is mandatory registration for manufacturers to notify FDA (Food and Drug Administration) about their intent to market a medical device. For any manufacturer, before they start marketing a medical device in United States, its mandatory to prove to FDA that it is subsequently equivalent to a device already available in the market. 510(k) notification is to demonstrate that the medical device is as safe and effective as other equivalent devices legally available in the market, and that is not subject to premarket approval. Until the applicant receives an order that declares the device as safe and effective, the applicant must not market the device.
