Food and Drug Administration FDA issued Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. Draft guidance document replaces prior 2018 draft guidance, intended to emphasize the importance of ensuring that devices are secure.
Food and Drug Administration FDA issued Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, draft guidance document for industry and FDA staff. Industry stakeholders have until July 7 to comment on proposed guidance.
The new guidance deals with quality system considerations and the content of premarket submissions for members of the medical device industry, as well as Food and Drug Administration staff.