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Software Bill of Materials for Medical Devices

The FDA is looking to make them mandatory

Wade Schroeder
Tue, 04/05/2022 - 12:02
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On May 12, 2021, President Biden signed the Executive Order on Improving the Nation’s Cybersecurity. Among other items in the order was a requirement that every vendor that supplies the federal government with software must provide a software bill of materials (SBOM) with their product.

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Given that the federal government spends nearly $100 billion a year on IT services, the executive order has put a spotlight on the concept of an SBOM and cybersecurity in general.

Nowhere are these issues more pressing than in the medical device industry, where lives depend on the development of safe and secure software. So today, let’s take a look at the SBOM and the role it plays in medical device manufacturing and cybersecurity.

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