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 1 of 6
PreSTAR vs eSTAR explained: PreSTAR is the voluntary FDA template for Q-Submissions, eSTAR is required for 510(k) and De Novo. How cybersecurity carries across.
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Medical device cybersecurity at each study stage: rodent, large animal, primate, and human trials, and what the FDA expects before your IDE and marketing submission.
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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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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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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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FDA Submission Issue Request (SIR) response strategy for cybersecurity: eSTAR prep checklist, common 524B gaps, and how to answer without restarting review.
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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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FDA AI device cybersecurity in 2026: the February 2026 premarket guidance, PCCPs, the draft AI guidance's 7 threats, and how to cover them under Section 524B.
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