US FDA Develops and Qualifies First Non-Clinical Assessment Model Tool as Part of the MDDT Program – MDDT SUMMARY OF EVIDENCE AND BASIS OF QUALIFICATION…
Posts tagged as “US FDA”
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for…
September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement
Center for Devices and Radiological Health (CDRH) Appeals Processes
Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
Expanded Access for Medical Devices
Statement on agency’s efforts to increase transparency in medical device reporting