Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-Ray, Laser and Ultrasonic Products
Posts published in March 2019
USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards
CDRH Proposes New IMDRF Work Item on Standards
USFDA Ethylene Oxide Sterilization for Medical Devices website
FDA Preps for Device Shortages as Another Sterilization Facility Will Close
FDA Panel Recommends New Postmarket Requirements for Breast Implants
FDA Posts Information about Ethylene Oxide Sterilization and Medical Devices
2019 Meeting Materials of the General and Plastic Surgery Devices Panel
FDA Panel: Too early to pull textured breast implants over cancer risk, need more data
ADVANCING CYBERSECURITY OF HEALTH AND DIGITAL TECHNOLOGIES