CDRH New Update

CDRHNew

Date: March 7, 2016

The following new items were added to the CDRH web pages on March 4, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Added Webcast Archive to Public Workshop - Advancing the Development of Biomarkers in Traumatic Brain Injury, March 3, 2016
• Archived Webcast and Presentation Slides added to Public Workshop - Patient and Medical Professional Perspectives on the Return of Genetic Test Results, March 2, 2016
• Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes - Draft Guidance for Industry and Food and Drug Administration Staff
• Emergency Use Authorizations: OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) - For Use with Cadaveric Oral Fluid - March 4, 2016
• Federal Register: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• 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
• Federal Register: Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments
• Federal Register: Unique Device Identification System; Editorial Provisions; Technical Amendment