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Volume XII, Number 183

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FDA Issues Draft Cybersecurity Guidance for Medical Devices

On April 8, 2022, the Food and Drug Administration (“FDA”) issued Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, a draft guidance document for industry and FDA staff. Industry stakeholders will have until July 7, 2022 to comment on the proposed guidance.

The FDA developed the draft guidance in response to increasing cybersecurity threats to the healthcare sector and growing use of wireless, Internet- and network-connected medical devices. The draft guidance provides recommendations regarding cybersecurity device design, labeling and documentation with the goal of facilitating an efficient premarket review process and ensuring that marketed medical devices are “sufficiently resilient to cybersecurity threats.”

The FDA previously issued guidance addressing premarket expectations in 2014 and proposed to update this guidance in 2018. The 2022 draft guidance, however, replaces the 2018 version and incorporates input from stakeholders at various public meetings, comments received on the 2018 version and recommendations from the Health Care Industry Cybersecurity Task Force Report. According to the FDA, the guidance “is intended to further emphasize the importance of ensuring that devices are designed securely, are designed to be capable of mitigating emerging cybersecurity risks throughout the Total Product Life Cycle, and to clearly outline [the] FDA’s recommendations for premarket submission content to address cybersecurity concerns.”

Copyright © 2022, Hunton Andrews Kurth LLP. All Rights Reserved.National Law Review, Volume XII, Number 110
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About this Author

In today’s digital economy, companies face unprecedented challenges in managing privacy and cybersecurity risks associated with the collection, use and disclosure of personal information about their customers and employees. The complex framework of global legal requirements impacting the collection, use and disclosure of personal information makes it imperative that modern businesses have a sophisticated understanding of the issues if they want to effectively compete in today’s economy.

Hunton Andrews Kurth LLP’s privacy and cybersecurity practice helps companies manage data and...

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