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.
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"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