Unverified50% confidenceFactExact time

In its 2023 cybersecurity guidance, FDA explicitly requires medical device manufacturers to submit an SBOM (Software Bill of Materials) prior to market approval.

1

Sources

50%

Confidence

Long-term

Relevance

10/12/2026

First Seen

Sources

Medical Imaging Software Development: 10 Key Questions for Choosing the Right Technology Partner

Related Entities

FDAcompany SBOMconcept

Related Claims

Unverified软件物料清单（SBOM）是NIST和CISA大力推动的供应链安全标准，2021年美国行政令14028将其纳入联邦软件采购要求71% similar Unverified美国FDA对II类或III类医疗器械要求510(k)上市前通知或PMA预市批准，涵盖结构强度、失效模式分析、电气安全和临床试验69% similar

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