CDRH New Update

CDRHNew

Date: June 1, 2016

The following new items were added to the CDRH web pages on May 31, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Federal Register: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; 7/21-22/16
• Federal Register: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; 8/10/16
• FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - Draft Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards and...
• FDA Voice Blog: Celebrating a Year of the Expedited Access Pathway Program for Medical Devices
• Federal Register: Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System
• Meeting Materials posted for June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
• Meeting Notice: August 10, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
• Meeting Notice: July 21-22, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
• Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available)