Potential Problems with Battery-Powered Mobile Medical Carts in Health Care Facilities that May Result in Fire: Letter to Health Care Professionals

December 27, 2016 Dear Health Care Professionals, Health Care Facility Administrators The FDA is warning health care facilities of potential safety risks associated with battery-powered mobile medical carts. The FDA is aware of reports of explosion, fires, smoking, or overheating of equipment that required hospital evacuations associated with the batteries in these carts. ANALYSIS OF…

FDA Voice blog: Managing Medical Device Cybersecurity in the Postmarket: At the Crossroads of Cyber-safety and Advancing Technology

By:  Suzanne B. Schwartz, M.D., M.B.A. Protecting medical devices from ever-shifting cybersecurity threats requires an all-out, lifecycle approach that begins with early product development and extends throughout the product’s lifespan. Today, we’re pleased to announce that industry now has advice from FDA across this product continuum with the release of a final guidance on the…

Public Workshop

The Food and Drug Administration (FDA), is announcing the following public workshop entitled “Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI).” The purpose of the public workshop is to obtain stakeholders’ input on the coordination of registries for Devices Used for Acute Ischemic Stroke Intervention. FDA is soliciting input on…

Webinar – Postmarket Management of Cybersecurity in Medical Devices Final Guidance

<!– –> <!– Page Last Updated: 12/27/2016 –> Page Last Updated: 12/27/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…

ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication

[Posted 12/23/2016] AUDIENCE: OBGYN, Internal Medicine, Infectious Disease, Family Practice ISSUE: The FDA is alerting physicians who care for pregnant women meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, that the U.S. commercial testing facility, Laboratory Corporation of America (LabCorp), has reported some false positive results from the ZIKV Detect test….