Every article in our archive tagged Postmarket.
Clearance is not the end of cybersecurity work. Once a device is on the market, the manufacturer has to watch for new vulnerabilities in its software and components, assess how they affect patient safety, ship patches on a documented schedule, keep the SBOM current, and coordinate disclosure with researchers and customers.
For cyber devices, Section 524B requires a postmarket plan in the premarket submission, so the FDA reviews how you will do this before the device ships. The articles below cover monitoring sources, update cadence, end-of-support decisions, CAPA, incident response and what happens when postmarket work falls behind.
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 18 articles tagged Postmarket · Page 1 of 2
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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The FDA PCCP guidance isn't AI-only. Use a predetermined change control plan for cybersecurity patches, firmware updates, and SBOM component swaps.
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What happens if you fail an FDA cybersecurity inspection: the 483-to-consent-decree enforcement ladder and the commercial fallout for device makers.
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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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FDA Section 524B applies to any new premarket submission for a cyber device, including legacy platforms.
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What medical device cybersecurity actually costs in 2026: four cost drivers, fixed-fee vs hourly pricing, and premarket vs postmarket budget lines.
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The threat intelligence sources medical device manufacturers should monitor to satisfy FDA Section 524B postmarket obligations: H-ISAC, CISA KEV, ICS.
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A subsection-by-subsection walkthrough of FDA Section 524B for cyber medical devices: what §524B(a), (b)(1), (b)(2), (b)(3), (b)(4), and (c) require.
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How to run CAPA for medical device cybersecurity findings: when a vulnerability or FDA deficiency triggers a CAPA, and what evidence closes it out.
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How Health Canada regulates medical device cybersecurity in 2026: device and IVDD classification, licence evidence routes, MDSAP reliance, and Section 59 reporting.
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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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How to design, isolate, and defend the update channel for connected medical devices - signed manifests, dual-bank A/B, rollback protection, HSM-backed.
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