2023-06646: Cybersecurity in Medical Devices: Refuse To Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under section 524B of the FD&C Act of the FD&C Act." FDA generally intends not to issue "refuse to accept" (RTA) decisions for premarket submissions submitted for cyber devices based solely on information required by the new amendments to the FD&C Act for ensuring cybersecurity of devices before October 1, 2023, but instead, work collaboratively with sponsors of such premarket submissions as part of the interactive and/or deficiency review process.
The agency’s own summary, as published.
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