What is required for a 510(k) Premarket Notification submission?

For a 510(k) Premarket Notification submission, demonstrating substantial equivalence to a marketed device is the primary requirement. This means that the new device must be shown to be as safe and effective as an already legally marketed device, which serves as the predicate. The focus on substantial equivalence allows for a streamlined review process compared to the more rigorous Premarket Approval (PMA) process that typically requires extensive clinical data.

While other elements such as conducting a risk assessment or submitting clinical trial results may be important in broader regulatory contexts, they are not specifically required for the 510(k) submission. Additionally, obtaining a Humanitarian Device Exemption relates to different regulatory pathways for devices intended for rare conditions and does not apply to 510(k) submissions. Thus, establishing substantial equivalence is central to the 510(k) process and is essential for regulatory approval.