Medical device cybersecurity is a dynamic and evolving space. As more devices enter the market and connect to the internet, the risk of these devices being compromised increases—ultimately increasing the risk to patient safety.
• Submission plans must describe how manufacturers will track and address cybersecurity issues after the device goes to market. As a result, this work is ongoing and requires a proactive approach to cybersecurity, which they can facilitate with vulnerability assessments and pen tests. • Manufacturers must develop a software bill of materials for devices. An SBOM is a formal and standardized listing of all of the medical device's software components, dependencies and metadata. It should encompass open-source and third-party software, firmware and binaries, cloud resources, and application programming interfaces with which devices interact or push data. Submitting an SBOM is now part of FDA filings.
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