Regulatory Affairs | FDAnews

Home » Topics » Medical Devices » Regulatory Affairs

January 31, 2023
FDA Issues Final Guidance on SLA Lasers
January 30, 2023
New Mentoring Opportunity Available Through Pediatric Device Consortia Grants Program
The FDA has invited devicemakers to apply for funding to develop medical devices for children through the FDA’s Pediatric Device Consortia grants program.
January 30, 2023
FDA Analysis of Global UDI Database Shows Increasing Submissions
The database has almost doubled in size since 2019.

January 30, 2023
CardioRenal Systems’ RenalGuard Therapy Gets Breakthrough Nod
January 27, 2023
Correction: Medtronic Updates HeartWare Ventricular Assist Device Battery Recall
January 27, 2023
FDA Analysis of Global UDI Database Shows Increasing Submissions
January 27, 2023
FDA Labels Datascope/Getinge, Emergent Device Recalls as Class 1
January 26, 2023
IceCure Tumor-Freezing Pump Receives Patent Nod

January 25, 2023
Califf Says Wearable Sensors Must Be Part of Restructuring of Evidence Generation
January 25, 2023
Medtronic Updates HeartWare Ventricular Assist Device Battery Recall
January 24, 2023
AdvaMed Defends Ethylene Oxide Sterilization
January 24, 2023
DePuy Pays $9.75 Million in Anti-Kickback Settlement
January 24, 2023
Califf Says Wearable Sensors Must Be Part of Restructuring of Evidence Generation