CDRH New Update

CDRHNew

Date: November 3, 2015

The following new items were added to the CDRH web pages on November 2, 2015. Previous CDRH New Items can be found on theCDRHNew Page.

• Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens - Guideline for Industry and Food and Drug Administration
• Federal Register: Information To Support a Claim of Electromagnetic Compatibility of Electrically Powered Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay
• Summary Information for: MiniMed 530G System with Threshold Suspend featuring SmartGuard technology
• MQSA National Statistics
• Summary Information for: Optune™ (Formerly the NovoTTF-100A System)
• Summary Information for: PD-L1 IHC 22C3 pharmDx
• Summary Information for: PD-L1 IHC 28-8 pharmDx
• Summary Information for: SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System