Tagged · FDA

FDA articles.

Every article in our archive tagged FDA.

SPDF· Jun 25, 2026

CI/CD Security Gates for Medical Devices

How to wire SAST, SBOM, secrets, container, and signature gates into a medical-device CI/CD pipeline so the SPDF produces the evidence FDA reviewers.

#SPDF#CI/CD#DevSecOps

Read article

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.

#FDA#Postmarket#Enforcement

Read article

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.

#Section 524B#Legacy Devices#Postmarket

Read article

Pricing· Jun 20, 2026

Medical Device Cybersecurity Cost (2026)

What medical device cybersecurity actually costs in 2026: four cost drivers, fixed-fee vs hourly pricing, and premarket vs postmarket budget lines.

#Pricing#Budget#FDA

Read article

FDA· Jun 18, 2026

SPDF and IEC 62304 Mapping: FDA Cyber

How SPDF activities map to IEC 62304 software lifecycle processes - the exact crosswalk FDA reviewers expect, where they overlap, and where 62304 falls.

#SPDF#IEC 62304#FDA

Read article

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.

#Section 524B#FDA#Premarket

Read article

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.

#CAPA#QMSR#FDA

Read article

Risk Management· Jun 18, 2026

FMEA vs Threat Modeling for Medical

FMEA covers random and systematic failure modes; threat modeling covers adversarial action.

#FMEA#Threat Modeling#ISO 14971

Read article

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.

#HHS 405(d)#HICP#FDA

Read article

Pen Testing· Jun 15, 2026

FDA Pen Test Timing: How Recent Must Your

What the FDA's Feb 3, 2026 guidance expects for penetration test recency, version-match, post-change re-testing, and pre-submission remediation, plus.

#Penetration Testing#FDA#Section 524B

Read article

Compliance· Jun 14, 2026

HIPAA and Medical Device Manufacturers

When HIPAA applies to medical device manufacturers, how the 2025 Security Rule NPRM raises the bar, and how HIPAA obligations intersect with the FDA's.

#HIPAA#Business Associate#Compliance

Read article

Interoperability· Jun 13, 2026

EHR/EMR Medical Device Integration

Which EHR and EMR systems medical devices connect to (Epic, Oracle Health, MEDITECH, Allscripts, athenahealth), the integration protocols (HL7, FHIR.

#EHR#EMR#Interoperability

Read article

Ready when you are

Get FDA cleared without the cybersecurity headaches.

30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.