Lexology April 20, 2022
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(“FDA”) issued Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, a draft guidance document for industry and FDA staff.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The FDA developed the draft guidance in response to increasing cybersecurity threats to the healthcare sector and growing use of wireless, Internet- and network-connected medical devices. The draft guidance provides recommendations regarding cybersecurity device design, labeling and documentation with the goal of facilitating an efficient premarket review process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...
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