Date: June 13, 2016
The following new items were added to the CDRH web pages on June 10, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Dissemination of Patient-Specific Information From Devices by Device Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150010 added)
- Federal Register: Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression Device
- Presentation and Transcript added to Artificial Pancreas: A Dialogue between the FDA and the Diabetes Community - June 2, 2016