FDA Alerts
Former Medical Device Manufacturer Employee Pleads Guilty to Forging FDA Clearance Letters
FDA Clears Ethos Automated Ultrasound Probe Cleaner Disinfector
FDA Clears Ethos Automated Ultrasound Probe Cleaner Disinfector
FDA Issues Guidance on Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act
FDA Issues Draft Guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
FDA Updates Cybersecurity Playbook for Health Care Organizations
Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing
GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of the Backup Batteries that May Cause Unexpected Shut Downs