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 22^nd, 2023, and approved by OIRA on March 27^th.

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

 

For more details about this guidance document, including a commentary on its current deficiencies, see my article at CFSN Detailed Analysis - https://patrickcoyle.substack.com/p/fda-publishes-refuse-to-accept-policy - subscription required.