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Every article in our archive tagged SPDF.
Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
Showing 6 of 6 articles tagged SPDF
Where FDA premarket cybersecurity artifacts live in an ISO 13485 / QMSR quality system: DHF, risk management file, DMR, and postmarket - clause-by-clause map.
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How to wire SAST, SBOM, secrets, container, and signature gates into a medical-device CI/CD pipeline so the SPDF produces the evidence FDA reviewers.
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How to document update cadence for an FDA §524B submission: the regular cycle and the out-of-cycle expedited path reviewers expect under §524B(b)(2)(B).
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How SPDF activities map to IEC 62304 software lifecycle processes - the exact crosswalk FDA reviewers expect, where they overlap, and where 62304 falls.
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What the FDA's Feb 3, 2026 final premarket cybersecurity guidance expects from a medical device incident response plan, who owns it, and the documents.
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FDA cybersecurity documentation requirements (2026): SPDF artifacts, Section 524B evidence, SBOM, threat model, testing, and labeling reviewers expect.
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