documents: 2023-20955
title | type | abstract | document_number | html_url | pdf_url | public_inspection_pdf_url | publication_date | agencies | excerpts |
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Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.'' As more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effectiveness includes adequate medical device cybersecurity, as well as its security as part of the larger system. This final guidance supersedes the final guidance ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,'' issued October 2, 2014. | 2023-20955 | https://www.federalregister.gov/documents/2023/09/27/2023-20955/cybersecurity-in-medical-devices-quality-system-considerations-and-content-of-premarket-submissions | https://www.govinfo.gov/content/pkg/FR-2023-09-27/pdf/2023-20955.pdf | https://public-inspection.federalregister.gov/2023-20955.pdf?1695732340 | 2023-09-27 | [ "Health and Human Services Department", "Food and Drug Administration" ] |
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.'' As more medical devices are becoming... |