Every article in our archive tagged FDA.
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 12 of 67 articles tagged FDA · Page 5 of 6
FDA cybersecurity documentation requirements (2026): SPDF artifacts, Section 524B evidence, SBOM, threat model, testing, and labeling reviewers expect.
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Performing a thorough cybersecurity risk analysis for a medical device isn't optional once your product qualifies under Section 524B of the FD&C Act.
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The biggest MedTech startup mistake isn't the tech. See why clarity, FDA planning, quality systems, and cybersecurity decide whether you clear review.
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The QMSR replaced the Quality System Regulation with ISO 13485:2016. Learn what changed, what did not, and how cybersecurity work fits the new structure.
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Cybersecurity Metrics for FDA Compliance for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.
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The 14 medical device cybersecurity standards FDA reviewers expect - ISO 14971, IEC 62304/81001-5-1, AAMI TIR57/TIR97, UL 2900 - mapped to SPDF artifacts.
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What a 510(k) really costs: FDA user fees, small business discounts, testing, cybersecurity work and consultant spend, plus how De Novo and PMA costs compare.
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Search the FDA 510(k), De Novo, and PMA databases for cybersecurity precedent, product codes, and predicate devices before a Section 524B premarket filing.
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RTOS security explained for medical devices: attack surface, isolation controls, secure boot, SBOM, and what FDA guidance recommends documented.
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Modular PMA Submission explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.
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Medical device authentication and access control: what the FDA's Feb 2026 guidance expects for credentials, privilege levels, biometrics, and audit logs.
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FDA 2026 medical device cybersecurity labeling requirements: interfaces, SBOM, secure configuration, update/patch steps - and mistakes that cause review.
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