CDRH New Update

CDRHNew

Date: March 8, 2016

The following new items were added to the CDRH web pages on March 7, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Alternative Standards #24: Approval of an Alternative Standard for Using the Quality Assurance Program Recommended by the ACR Digital Mammography Quality Control Manual for Full-Field Digital Mammography Systems, for Systems without Advanced Imaging Cap.
• Summary Information for: Axium Neurostimulator System
• Summary Information for: Blazer Open-Irrigated Ablation Catheter System
• Federal Register: Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails; Guidance for Industry and Food and Drug Administration Staff; Availability
• Meeting Notice: April 20, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
• Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
• Summary Information for: Sharps Terminator