FDA Cybersecurity for Medical Devices
One senior US-based team for the whole FDA cybersecurity scope: design, submission, testing, deficiency response, and postmarket. Built to Section 524B and the February 3, 2026 premarket guidance.
Direct answer
FDA cybersecurity is the set of design, documentation, and testing evidence a medical device manufacturer must produce to satisfy Section 524B of the FD&C Act and the FDA's February 3, 2026 premarket cybersecurity guidance. It spans the full product lifecycle: a Secure Product Development Framework and threat model during design, an SBOM with VEX and penetration test evidence at submission, and vulnerability monitoring, coordinated disclosure, and patch delivery after clearance. Blue Goat Cyber owns that scope end to end for 510(k), De Novo, PMA, and IDE programs.
How teams engage us
Four entry points, depending on where your device is today. Every one starts with a free 30-minute call with a senior engineer and a mutual NDA.
Gap analysis
You are not sure what the FDA will ask for.
A senior engineer reviews your architecture and existing documentation against Section 524B and the February 2026 guidance, then returns a point-by-point gap list with the artifact that closes each one.
Run the readiness checkDesign-phase support
You are still building and want to avoid rework.
We embed alongside your engineering team, set the security architecture and control selection, and build the SPDF into your existing QMSR or ISO 13485 processes before the code is frozen.
Secure product designSubmission package
Your device is nearly done and the submission is next.
We deliver every cybersecurity artifact the reviewer expects, formatted for the current eSTAR template and traceable back to the threat model and risk assessment.
Premarket cybersecurityDeficiency response
You already submitted and got an AI or hold letter.
Point-by-point reviewer-ready responses inside your 180-day clock, with each response mapped to the reviewer comment and the specific Section 524B clause it answers.
Deficiency responseFDA cybersecurity services across the device lifecycle
Each phase links to the service page that owns the work. Most manufacturers engage us for two or three of these at once.
Design
- Secure MedTech product designSecurity architecture, trust boundaries, cryptography and key management, secure boot and update strategy.
- Medical device threat modelingSTRIDE threat model with data flow diagrams, multi-patient harm view, and updateability view, aligned to ANSI/AAMI SW96:2023 and ISO 14971.
Submission
- FDA premarket cybersecurityThe full 18-artifact package for 510(k), De Novo, PMA, and IDE, delivered eSTAR-ready under Section 524B(b)(1) through (3).
- Medical device penetration testingDevice, firmware, wireless, cloud, and mobile attack surfaces tested by senior engineers, with findings traced to the threat model.
- FDA-compliant SBOM servicesSPDX or CycloneDX SBOM with CISA minimum elements, CVE mapping, VEX statements, and end-of-support dates.
- FDA deficiency responseHold letters, refuse-to-accept decisions, and AI cybersecurity deficiencies closed on the first resubmission.
Postmarket
- FDA postmarket cybersecuritySBOM monitoring, coordinated vulnerability disclosure, threat monitoring, incident response, and patch validation as one annual engagement.
- Postmarket SBOM and VEX monitoringContinuous component-to-CVE matching with triage in device context, so your team gets decisions instead of a raw feed.
- Legacy device cybersecurityCleared devices built before Section 524B brought up to the current postmarket obligations without a full redesign.
What the FDA expects, in reviewer order
The cybersecurity evidence a reviewer looks for, and whether it belongs to the premarket submission, the postmarket program, or both.
| Artifact | What it contains | Phase |
|---|---|---|
| Security architecture views | Global system, multi-patient harm, use case, and updateability views | Premarket |
| Threat model | STRIDE analysis with assets, threat actors, attack paths, and safety impact | Premarket |
| Security risk assessment | Traceability from vulnerability to control to residual risk under ISO 14971 | Premarket |
| Cybersecurity controls | Controls addressing the FDA risk control categories, with verification evidence | Premarket |
| SBOM plus VEX | Machine-readable SBOM, support levels, end-of-support dates, CVE applicability | Both |
| Testing evidence | Penetration testing, fuzz testing, vulnerability scanning, and SCA reports | Premarket |
| Cybersecurity management plan | Monitoring sources, response timelines, patch delivery, and disclosure policy | Both |
| Cybersecurity labeling | Customer security guide, SBOM disclosure, and end-of-support communication | Both |
| Metrics and monitoring | Measures that show the controls stay effective after clearance | Postmarket |
The full 18-artifact breakdown, with what each one has to prove, lives on the FDA premarket cybersecurity service page. For the underlying regulation, see our guide to FDA cybersecurity guidance and Section 524B requirements explained.
Cost and timeline
Every engagement is a fixed fee, quoted in writing within 24 hours of the discovery call. No hourly billing and no surprise change orders.
Software-only device
$65k to $90k
SaMD, cloud, and mobile scope. Typically 6 to 8 weeks to a submission-ready binder.
Connected device
$90k to $125k
Firmware, wireless, and cloud attack surfaces. Typically 8 to 10 weeks.
Complex or PMA
$125k to $150k+
Multi-component systems, AI/ML, or PMA-class traceability depth. Scoped per program.
Postmarket is priced separately as an annual engagement. Deficiency response is scoped against the letter.
Find out where you stand in a few minutes.
Check whether Section 524B applies to your device, then score your submission readiness against the current guidance.
FDA cybersecurity FAQs
Talk to a senior engineer, not a sales rep.
Free 30-minute call, mutual NDA signed first, and a fixed-fee quote within 24 hours. We will tell you straight if you do not need us.