FDA Finalizes Guidance On Medical Device Manufacturer Cybersecurity Responsibilities

On September 27, 2023, FDA issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This final guidance updates a draft guidance of the same title issued on April 8, 2022, discussed in a previous Ropes & Gray alert, and replaces the agency's 2014 final guidance titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," analyzed by Ropes & Gray here. While the new final guidance is largely similar to the April 2022 draft, it provides more detailed recommendations on conducting cybersecurity risk assessments, interoperability considerations, and documents to be included in premarket submissions to FDA.