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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).

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