FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CYBERSECURITY IN MEDICAL DEVICES: QUALITY SYSTEM CONSIDERATIONS AND CONTENT OF PREMARKET SUBMISSIONS; GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, June 27 -- Food and Drug Administration has issued a notice called: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on June 27 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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." This guidance updates the previous version of the guidance, of the same title, issued on September 27, 2023, and fin...