FDA Issues Final Guidance on the 510(k) Third Party Review Program
Posts published in “Premarket Notification – 510(k)”
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
Bone Anchors – Premarket Notification (510(k)) Submissions
FDA eSTAR Pilot Program
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)]
Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid
Special Premarket Notification [510(k)] Pathway
FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051