CDRH New Update

CDRHNew

Date: March 22, 2017

The following new items were added to the CDRH web pages on March 21, 2017. Previous CDRH New Items can be found on the CDRHNew Page.

• 24 Hour Summary posted for March 17, 2017 Ophthalmic Devices Panel of the Medical Devices Advisory Committee
• Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting for Custom Device Exemption
• Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) (Updated)
• Emergency Use Authorization - Gene-RADAR® Zika Virus Test (Nanobiosym Diagnostics, Inc.)
• Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (Updated)
• Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available)