What does the FDA’s Draft of Cybersecurity Guidance bring 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(“FDA”) issued Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, a draft guidance document for industry and FDA staff. 

• Draft Contents

The FDA developed the draft guidance in response to increasing cybersecurity threats to the healthcare sector and the growing use of wireless, Internet- and network-connected medical devices. The draft guidance provides recommendations regarding cybersecurity device design, labeling, and documentation to facilitate an efficient premarket review process and ensure that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

• Background

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 The 2022 draft guidance, however, replaces the 2018 version and incorporates input from stakeholders at various public meetings, comments received on the 2018 version, and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 HealthCare Industry Cybersecurity Task Force Report. 

• Goals

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 FDA’s recommendations for premarket submission content to address cybersecurity concerns.

Industry stakeholders can comment on the proposed guidance until July 7, 2022.

Direct Publication Source: https://www.huntonprivacyblog.com/2022/04/20/fda-issues-draft-cybersecurity-guidance-for-medical-devices/