We use cookies and similar technologies to measure how our site and advertising perform. You can accept or decline. Declining keeps the site fully usable and only turns off measurement. See our privacy policy.
Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
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 293 articles · Page 1 of 25
Security requirements testing verifies your design inputs; penetration testing attacks the built device. What the FDA's Feb 2026 guidance expects for each.
Read article
Embedded Linux vs Windows IoT Enterprise LTSC for medical devices: attack surface, isolation, secure boot, patching, SBOM, and what FDA reviewers actually look at.
Read article
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.
Read article
Breakthrough Device designation speeds FDA interaction but waives no cybersecurity requirement. Here is how Section 524B applies to Breakthrough devices in 2026.
Read article
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.
Read article
Where FDA premarket cybersecurity artifacts live in an ISO 13485 / QMSR quality system: DHF, risk management file, DMR, and postmarket - clause-by-clause map.
Read article
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.
Read article
De-identification vs anonymization for medical devices: HIPAA Safe Harbor, GDPR Recital 26, and what the FDA expects for AI/ML training data and postmarket telemetry.
Read article
The three types of 510(k) - Traditional, Special, and Abbreviated - explained side by side, with the cybersecurity implications of each under Section 524B.
Read article
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.
Read article
AAMI SW96 didn't formally replace TIR57, but SW96 is now the FDA-recognized normative standard. Here's what changed and what the FDA expects in 2026.
Read article
FDA Submission Issue Request (SIR) response strategy for cybersecurity: eSTAR prep checklist, common 524B gaps, and how to answer without restarting review.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.
