CDRH New Update

CDRHNew

Date: September 22, 2016

The following new items were added to the CDRH web pages on September 21, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Federal Register: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 045
• Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System
• Presentation and Transcript posted for the Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies Webinar - Wednesday, September 14, 2016
• Federal Register: Reporting of Computational Modeling Studies in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability