Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

On 8 April 2022 the FDA published draft guidance on cybersecurity in medical devices for industry and FDA staff. Comments may be submitted until 7 Jul 2022.

This guidance is intended to provide recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations can facilitate an efficient premarket review process and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats.

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