Insights

Field notes from the MedTech security trenches.

Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.

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Showing 12 of 284 articles · Page 1 of 24

FDA Compliance· Jun 4, 2026

Does Device Class Decide FDA Cybersecurity Requirements?

Class I, II, III doesn't decide your FDA cybersecurity burden. Section 524B's cyber-device test and whether you file a premarket submission do. Here's how it actually works.

#FDA #Section 524B #Device Classification

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Penetration Testing· Jun 3, 2026

Does the FDA Accept AI Pen Testing for Medical Devices?

What the FDA's Feb 2026 premarket cybersecurity guidance says (and doesn't say) about AI-run penetration testing, where AI helps, where it fails a 524B.

#Penetration Testing #AI #FDA

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FDA· Jun 3, 2026

FDA Cybersecurity Deficiencies in PMA Submissions: AI Requests, Major Deficiencies, and Complete Response Letters

How the FDA flags cybersecurity gaps in PMA submissions - RTF, Major Deficiency, Approvable, and Complete Response Letters for combination products - and how to respond.

#FDA #PMA #Deficiency Response

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FDA· Jun 3, 2026

PMA Supplement vs Real-Time vs 30-Day Notice for Cybersecurity Changes

Which PMA submission type a cybersecurity change requires - 180-day supplement, Real-Time, Special, 30-day notice, or annual report - and the decision logic under Section 524B.

#FDA #PMA #Premarket

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FDA· Jun 3, 2026

FDA Cybersecurity Major vs Minor Deficiency: How Reviewers Grade Findings

How the FDA distinguishes Major from Minor cybersecurity deficiencies in 510(k) and PMA reviews, the response-window difference, and how to keep findings out of the Major column.

#FDA #Deficiency Response #510(k)

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FDA· Jun 3, 2026

De Novo Cybersecurity Requirements: What the FDA Expects

How cybersecurity expectations apply to De Novo submissions under Section 524B - SPDF, SBOM, threat model, testing - and where De Novo differs from 510(k) and PMA.

#FDA #De Novo #Premarket

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Standards· Jun 3, 2026

IEC 81001-5-1 vs AAMI SW96: Which Standard for Your SPDF?

IEC 81001-5-1 vs AAMI SW96 compared side-by-side: scope, lifecycle vs risk focus, FDA recognition, and which to anchor your Secure Product Development Framework on.

#Standards #IEC 81001-5-1 #AAMI SW96

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Pen Testing· Jun 3, 2026

CAN Bus and CANopen Vulnerabilities in Medical Devices

Where CAN/CANopen shows up inside medical devices, the attack paths FDA reviewers want modeled, and the controls that actually hold up under pen test.

#Pen Testing #Hardware #Threat Modeling

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Pen Testing· Jun 3, 2026

Fuzz Harness Generation for Medical Devices: HL7, DICOM, BLE GATT, MQTT, CoAP, and Proprietary Binary Protocols

How to build FDA-defensible fuzz harnesses for the protocols medical devices actually speak. Per-protocol tooling, grammar sources, seed corpus strategy, coverage signal, and where AI helps (and where it doesn't).

#Pen Testing #Fuzzing #Protocols

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Standards· Jun 3, 2026

CVSS 3.1 vs 4.0 for Medical Devices: Vector Strings, Scoring, and What FDA Reviewers Want

CVSS 3.1 vs 4.0 for medical devices compared - vector strings explained metric by metric, why 4.0's Safety and Automatable metrics matter for patient harm, and how to handle the transition in FDA submissions and postmarket VEX.

#CVSS #VEX #SBOM

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