Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
Title:
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
Origin/Publisher:
FDA
Document Type:
Guidance
Content:
This guidance describes recommendations regarding the cybersecurity information to be submitted for devices under the following premarket submission types, when submitted to the Center for Devices and Radiological Health (CDRH) or the Center
for Biologics Evaluation and Research (CBER).