CDRH New Update-

CDRHNew

Date: December 27, 2016

The following new items were added to the CDRH web pages on December 23, 2016. Previous CDRH New Items can be found on the CDRHNew Page.

• Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Unique Device Identification System
• Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - Guidance for Industry and Food and Drug Administration Staff
• Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 046
• Federal Register: Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2017 Proposed Guidance Development
• Federal Register: Medical Devices; Neurological Devices; Classification of the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment