CDRH New - October 2, 2019

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 1, 2019. To view listings for other dates, see CDRH New - News and Updates.

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication Consumer Information on: Axonics Sacral Neuromodulation (SNM) System - P190006 Meeting Notice: November 13-14, 2019: Immunology Devices Panel of the Medical Devices Advisory Committee Meeting MQSA National Statistics