CDRH New Update

The following new items were added to the CDRH web pages on October 3, 2018. Previous CDRH Newitems can be found on the CDRH New webpage.

• CDRH Fiscal Year 2019 (FY 2019) Proposed Guidance Development
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170080 added)
• Federal Register: Process to Request a Review of the Food and Drug Administration's Decision not to Issue Certain Export Certificates for Devices
• Federal Register: Website Location of Center for Devices and Radiological Health Fiscal Year 2019 Proposed Guidance Development