Unraveling 510(k) Premarket Notification: An Essential Guide | Scilife

To legally market a medical device or IVD for human use in the US market, appropriate documentation must be submitted to the US regulatory authority, the FDA (Food and Drug Administration) Depending on the device risk class, the US regulatory submission can either be a 510(k), Premarket Approval (PMA), or a De Novo request. The type of regulatory submission you need is tied to the risk classification of your medical device: The 510(k) is a premarket notification required for medical devices and.