Every article in our archive tagged Section 524B.
Showing 12 of 24 articles tagged Section 524B · Page 1 of 2
Section 524B applies to a connected auto-injector when the device constituent has software and any electronic interface, regardless of whether CDER or CDRH leads review.
Read article
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).
Read article
FDA Section 524B applies to any new premarket submission for a cyber device, including legacy platforms. What attaches, what postmarket rules cover the rest.
Read article
How SPDF activities map to IEC 62304 software lifecycle processes - the exact crosswalk FDA reviewers expect, where they overlap, and where 62304 falls short.
Read article
The threat intelligence sources medical device manufacturers should monitor to satisfy FDA Section 524B postmarket obligations: H-ISAC, CISA KEV, ICS advisories, NVD, MITRE ATT&CK for ICS, and vendor PSIRTs.
Read article
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, what artifacts satisfy each, and the deficiency patterns reviewers flag most.
Read article
How to run CAPA for medical device cybersecurity findings: when a vulnerability or FDA deficiency triggers a CAPA, what evidence closes it, and how the QMSR loop ties to §524B postmarket obligations.
Read article
How HHS 405(d) and the Health Industry Cybersecurity Practices (HICP) Medical Device Security practice maps to FDA Section 524B artifacts, and how manufacturers should align their premarket and postmarket programs to satisfy both reviewers and hospital procurement.
Read article
What the FDA's Feb 3, 2026 guidance expects for penetration test recency, version-match, post-change re-testing, and pre-submission remediation, plus when a delta re-test will do and when you need a full one.
Read article
What the FDA expects from infusion pump cybersecurity submissions in 2026: threat model focus areas, Section 524B evidence, and the deficiencies that delay clearance.
Read article
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 reviewers look for.
Read article
IEC 62304 software safety classes (A/B/C) and FDA device classes (I/II/III) are not equivalent. See how each one drives cybersecurity evidence under Section 524B and the Feb 3, 2026 guidance.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.
