US, Canada Setting Trend For Global Cybersecurity Guidance
A draft IMDRF guidance released this month aims to set the trend for how regulators around the world oversee cybersecurity of medical devices. According to experts, the document also foreshadows what sponsors can expect from the US FDA in areas such as developing a software bill of materials, as the agency updates its own cybersecurity guidances.
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As head of the device center’s emergency response program, Schwartz oversees a broad range of issues, from medical device shortages to cybersecurity vulnerabilities. We talk to her in this Medtech Insight profile.
A final IMDRF guidance on medical device cybersecurity reinforced US and Canadian regulatory thinking on issues such as a total product life cycle approach, shared responsibility and creating a software bill of materials.