Public Meeting – Communications About the Safety of Medical Devices
Posts published in “United States Food and Drug Administration – US FDA”
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)]
FDA Issues Draft Guidance on Arthroscopy Pump Tubing Sets
Radiology Devices: Reclassification of Medical Image Analyzers
FDA Recognizes New Version of ISO 14971, More Than 100 Other Consensus Standards
Public Workshop – Medical Extended Reality
Annual Reports for Approved Premarket Approval Applications (PMA)
Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions
Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices