Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." This guidance identifies cybersecurity issues that manufacturers should consider in preparing premarket submissions for medical devices in order to maintain information confidentiality, integrity, and availability.