The law firm of Hogan Lovells has an article about FDA’s finalized guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” They note:
FDA’s new final guidance replaces the April 2022 draft guidance of the same name, which we analyzed online here, and it also supersedes FDA’s 2014 final guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” There were more than 1,800 public comments on the draft version of the guidance, which FDA was required to finalize by the end of September, 2023. In announcing release of the final guidance, the agency emphasized how the “increased integration of wireless devices, electronic exchange of medical device-related information, and cybersecurity vulnerabilities and incidents, highlight the importance of having stronger cybersecurity measures.” The final version of the guidance mirrors closely the draft version, with the exceptions outlined below and implements many of the documentation expectations that FDA has been requesting over the last year.
Read the full article at Engage.
