Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Guidance for Industry and Food and Drug Administration Staff

Document Issued on: October 2, 2014

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The draft of this document was issued on June 14, 2013.

For questions regarding this document contact the Office of Device Evaluation at 301-796-5550 or Office of Communication, Outreach and Development (CBER) at 1-800-835-4709 or 240-402-7800.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of Device Evaluation

Office of In Vitro Diagnostics and Radiological Health

Center for Biologics Evaluation and Research

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