Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Digital Health, Labeling, Postmarket, Premarket, Safety - Issues, Errors, And Problems

Published

December 28, 2016

Last updated

March 7, 2019

Description

This document is a guidance for managing cybersecurity in medical devices, addressing labeling, postmarket, premarket, and safety issues.

Organization

Country / Region

United States

License

Other (Public Domain)

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