CPC Comments on FDA’s Draft Guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

On July 6, 2022, the CPC submitted a comment letter to FDA regarding the Agency’s draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” CPC greatly appreciates FDA’s efforts in the draft guidance to help establish Agency expectations for the types of cybersecurity activities and evidence required to gain approval and maintain medical devices. CPC’s comments seek clarity and offer suggestions for FDA’s consideration with respect to the scope and applicability of the draft guidance to software and firmware products that are used in combination with drugs and/or are regulated as drug primary mode of action combination products.