CDRH New Update

CDRHNew

Date: July 27, 2016

The following new items were added to the CDRH web pages on July 26, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Adaptive Designs for Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150030 added)
• Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 044
• Federal Register: Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes
• Federal Register: Unique Device Identification System: Form and Content of the Unique Device Identifier; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff