FDA finalizes advice on cybersecurity info to include in device submissions
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 They note: FDA’s new final guidance replaces the April 2022 draft guidance of the same name, which we analyzed online here, and it also supersedes FDA’s 2014 final guidance “Content of Premarket Submissions for Management […]