Tagged · FDA

FDA articles.

Every article in our archive tagged FDA.

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 67 articles tagged FDA · Page 4 of 6

FDA Compliance· Jun 11, 2026

Patch and Update Mechanism Testing

Section 524B(b)(2) makes patchability statutory. What the FDA's Feb 2026 guidance expects in the patch and update mechanism test evidence, the test cases.

#FDA #Section 524B #Patchability

Read article

Penetration Testing· Jun 11, 2026

DAST vs Penetration Testing for FDA Submissions

DAST is a subset of FDA-required penetration testing. What the Feb 2026 guidance expects in eSTAR Slot 7, and why a Burp scan alone will fail review.

#Penetration Testing #DAST #FDA

Read article

Strategy· Jun 10, 2026

Cybersecurity Before MVP vs After Market

How late cybersecurity changes affect medical device architecture, evidence, and remediation scope, without unsupported cost or delay estimates.

#Strategy #FDA

Read article

Secure Architecture· Jun 5, 2026

Secure Update Infrastructure for Medical Devices

How to design, isolate, and defend the update channel for connected medical devices - signed manifests, dual-bank A/B, rollback protection, HSM-backed.

#FDA #Section 524B #Secure Updates

Read article

FDA Compliance· Jun 4, 2026

Does Device Class Decide FDA Cybersecurity Scope?

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.

#FDA #Section 524B #Device Classification

Read article

Penetration Testing· Jun 3, 2026

FDA & 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

Read article

FDA· Jun 2, 2026

FDA Penetration Testing Requirements

What the FDA's Feb 2026 premarket guidance actually requires for medical device penetration testing - what's inside a real pen test, what's separate.

#FDA #Penetration Testing #Section 524B

Read article

FDA· Jun 2, 2026

Letter to File vs New 510(k)

When a cybersecurity change to a cleared device stays as a letter to file in the DHF, and when it forces a new 510(k). Decision framework and examples.

#FDA #510(k)#Section 524B

Read article

FDA· Jun 2, 2026

Special vs Traditional 510(k)

When the FDA accepts a Special 510(k) for cybersecurity changes - BLE, firmware signing, Secure Boot, SBOM swaps - and when it pushes you to Traditional.

#FDA #510(k)#Section 524B

Read article

FDA· Apr 10, 2026

How to Respond to an FDA Cybersecurity AI Request

Receiving an FDA cybersecurity Additional Information Request (AIR) doesn't mean your submission is dead. Aligned with the FDA's Feb 3, 2026 premarket.

#FDA #AI

Read article

FDA· Apr 10, 2026

ISO 27001 & SOC 2 vs FDA Medical Device Rules

Why ISO 27001 and SOC 2 don't satisfy FDA medical device cybersecurity: the gaps in Section 524B evidence and what reviewers require instead.

#FDA #Standards

Read article

FDA· Apr 9, 2026

510(k) Cybersecurity Requirements Every Maker Must Meet

FDA 510(k) cybersecurity requirements - threat model, SBOM, testing, postmarket plan - scaled across 510(k), De Novo, and PMA pathways under Section 524B.

#FDA #510(k)

Read article

Ready when you are

Secure your device before it reaches patients.

30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.

Book strategy session Explore services