FDA Releases Draft Guidance of Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has issued a series of recommendations for medical device manufacturers whose devices may be susceptible to cybersecurity risks.

Issued in mid-October, the FDA’s draft guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” updates information provided by the FDA in 2014 and details revised recommendations for device design, labeling and documentation to be included as part of premarket submissions for at-risk medical devices. The updated guidance is intended to address the rapidly-evolving cybersecurity landscape, as well as an increased understanding of actions that can be taken by device manufacturers to mitigate the threat.

Read the complete text of the FDA’s draft guidance with recommendations for medical devices susceptible to cybersecurity risks.

Electronic comments can be submitted through the Regulations.gov platform.

The FDA says that will also host a public workshop at the end of January to discuss specific aspects of the draft guidance in detail. Read further information about this workshop, including registration instructions.

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