What are the steps to prepare and submit a Premarket Notification (510(k)) application?
Premarket Notification 510(k) submissions for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). The Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) within CDRH are responsible for the processing and review of 510(k)s for marketing clearance in the U.S. Branches within these offices are organized according to medical scientific disciplines. ODE and OIVD staff includes biomedical engineers, physicians, microbiologists, chemists, etc., that performs scientific reviews of 510(k)s and other research (Investigational Device Exemption) and marketing applications (Premarket Approval). These individuals are commonly referred to as reviewers. It is their recommendation that determines whether a new device is substantially equivalent (SE) or not substantially equivalent (NSE).
For more information, please visit the Device Advice website.