Every article in our archive in FDA.
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Showing 12 of 55 articles in FDA · Page 1 of 5
Medical device cybersecurity at each study stage: rodent, large animal, primate, and human trials, and what FDA guidance recommends before your IDE and marketing submission.
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Review eight medical device cybersecurity documentation gaps against FDA guidance: SBOM, controls, labeling, testing, risk assessment, reports, anomalies, and threat models.
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Home use vs hospital device cybersecurity: which controls the HDO environment provides, which the device must carry itself, and how the FDA reviews each case.
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How your Indications for Use statement and predicate choice change the cybersecurity scope of a 510(k): use environment, harm ceiling, pen test scope, and Special 510(k) eligibility.
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Breakthrough Device designation speeds FDA interaction but waives no cybersecurity requirement. Here is how Section 524B applies to Breakthrough devices in 2026.
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Cleared under Section 524B but skipping postmarket cybersecurity? Here's what statute, regs, and FDA enforcement actually say - across 510(k), De Novo, PMA, PDP, and HDE.
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Q-Sub vs Pre-Sub for FDA cybersecurity: what they are, how they differ, and when to use a Pre-Submission to de-risk Section 524B threat models, SBOMs, and pen tests.
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When to use an FDA Submission Issue Request after a qualifying hold letter, how to frame cybersecurity questions, and why the formal response deadline still applies.
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Medical device pen testing under FDA vs EU MDR: the 5 FDA report elements, MDR Annex I §17.2/17.4, and how one report serves both submissions.
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A five-source workflow (510(k), De Novo, PMA, MAUDE, FOIA) for mining FDA cybersecurity precedent by product code before a Section 524B filing.
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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 2026 guidance recommends for IDE cybersecurity: informed consent, architecture views, SBOM, labeling, and what's not required yet.
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