CDRH New - January 27, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 21-24, 2020. To view listings for other dates, see CDRH New - News and Updates.

Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication CDRH's Experiential Learning Program Flow Re-Direction Endoluminal Device (FRED®) System - P180027 Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions - Guidance for Industry and FDA Staff Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170022 and DEN170073 added) Federal Register: Classification of the Radiological Computer Aided Triage and Notification Software Federal Register: Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer Federal Register: Reclassification of Medical Image Analyzers