Compliance· Sep 26, 2026
FDA Cybersecurity Deficiency Response Timeline Guide
FDA cybersecurity deficiency response timeline: the 180-day clock, how holds work for 510(k), De Novo and PMA, and a week-by-week plan to answer on time.
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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.
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Showing 12 of 14 articles in Compliance · Page 1 of 2
Compliance· Sep 26, 2026
What Is a Cyber Device Under FDA Section 524B?
What is a cyber device under FDA Section 524B? The three-part legal test, how the FDA reads internet connection, and a quick check for your own device.
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Compliance· Jul 23, 2026
Premarket Cybersecurity in Your QMS: ISO 13485 & QMSR
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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Compliance· Jul 23, 2026
CLIA Lab Cybersecurity: HIPAA & 21 CFR Part 11 (2026)
Cybersecurity for CLIA high-complexity labs: HIPAA, 21 CFR Part 11 data integrity, LIMS hardening, vendor patching, AI/cloud analytics, and CMS/CAP inspection readiness.
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Compliance· Jul 10, 2026
FDA PCCP Beyond AI: Cybersecurity & Firmware Uses
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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Compliance· Jun 26, 2026
Does FDA 524B Apply to Auto-Injectors?
FDA Section 524B applies to connected auto-injectors when the device constituent has software and any electronic interface, whether CDER or CDRH leads review.
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Compliance· Jun 23, 2026
FDA Cybersecurity Failure Consequences
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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Compliance· Jun 23, 2026
Documenting Update Cadence for an FDA Submission
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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Compliance· Jun 23, 2026
Does FDA 524B Apply to Legacy Medical Devices?
FDA Section 524B applies to any new premarket submission for a cyber device, including legacy platforms.
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Compliance· Jun 18, 2026
FDA Section 524B Subsections Explained
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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Compliance· Jun 18, 2026
CAPA and Medical Device Cybersecurity
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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Compliance· Jun 18, 2026
HHS 405(d) HICP Practice #9 for 524B
How HHS 405(d) and the Health Industry Cybersecurity Practices (HICP) Medical Device Security practice maps to FDA Section 524B artifacts, and how.
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