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AI-enabled device software functions guidance

Safeguard articles tagged "AI-enabled device software functions guidance" — guides, analysis, and best practices for software supply chain and application security.

1 article

Compliance

FDA Predetermined Change Control Plans for AI Devices: What Section 515C, the Guidance and 21 CFR 892.2055 Require

How an FDA PCCP lets an AI medical device ship model updates without a new 510(k): the statute, the guidance status, the first PCCP device rule and a gate.

Oct 22, 202612 min read

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