Thursday, March 30, 2023

Review - FDA Publishes ‘Refuse to Accept’ Policy Guidance Document

The Food and Drug Administration (FDA) published a notice of availability in the Federal Register (88 FR 19148-19150) for “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”. The actual guidance document is available here. This guidance document was sent to the OMB’s Office of Information and Regulatory Affairs (OIRA) on March 22nd, 2023, and approved by OIRA on March 27th.

The effective date of this new guidance document is March 29th, 2023.


For more details about this guidance document, including a commentary on its current deficiencies, see my article at CFSN Detailed Analysis - - subscription required.

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