![Patient talking to a doctor](https://public4.pagefreezer.com:443/content/FDA/30-04-2023T17:16/https://www.fda.gov/files/styles/medium_3/public/CDRHNewsroom-Haylard-Risk.jpg?itok=I-oAdm0Y)
Risk of Protection Failure in Certain O&M Halyard Respirators and Masks
Certain surgical respirators, surgical masks, and pediatric face masks by O&M Halyard do not meet quality and performance expectations.
Certain surgical respirators, surgical masks, and pediatric face masks by O&M Halyard do not meet quality and performance expectations.
The program aims to assist companies advance alternative and innovative ways to sterilize approved medical devices.
FDA issues a guidance for immediate implementation: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act.
Stay up to date as we continue to keep up our ongoing mission of protecting public health and spurring medical device innovation.
"Our center and the entire FDA stand ready to meet each challenge and opportunity in our continuing commitment to public health." - Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health