Full-Service FDA Premarket Cybersecurity for Digital Therapeutics
End-to-end FDA premarket cybersecurity for prescription DTx - mobile/web app, cloud, prescription auth, and SaMD-aligned threat model and SBOM.
Aligned to FDA's February 3, 2026 premarket cybersecurity guidance.
Digital therapeutics submissions are often the first time a software-only company encounters FDA's premarket cybersecurity expectations, and the package looks different from a hardware device: there's no firmware, the entire product is the app and the cloud, and the threat model has to focus on prescription integrity, content integrity, and the patient-clinician trust model. Our full-service premarket package for DTx delivers an SPDF, SaMD-tuned threat model, SBOM, pen testing, and architecture views aligned to the FDA 2026 final premarket guidance and to SaMD-specific considerations.
We build the threat model around the prescription pathway (who can issue / fulfill / modify a prescription, and what controls prevent unauthorized intervention), the content-delivery pathway (can a tampered intervention reach a patient?), and the data-collection pathway (PHI handling, sharing with clinicians, research-data export). Mobile app and cloud SBOMs are generated from the build pipeline with VEX. Pen testing exercises the mobile app under instrumented runtime, the cloud APIs for IDOR and cross-tenant leakage (DTx is multi-tenant by default), and the prescription/auth flow for replay and impersonation. Security architecture views include both the global system view and the multi-patient harm view - because DTx, like RPM, serves many patients from one cloud. Package is eSTAR-ready.
Layers we exercise in this engagement
The digital therapeutics system, from the outermost cloud and clinician surfaces down to the device itself. Highlighted layers are exercised by this fda premarket cybersecurity package.
- 01Clinician web UI Tested
- 02Cloud APIs Tested
- 03Mobile app (iOS / Android) Tested
- 04Push notification path Tested
- 05Backend data store Tested
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
FDA Premarket Cybersecurity Package engagement, end to end
Four phases, fixed fee, scoped to digital therapeutics architecture from kickoff onward.
- 01
Submission gap check
Existing artifacts mapped against Section 524B(b) and the Feb 2026 guidance; gaps flagged in one document.
- 02
Artifact production
Threat model, SBOM + VEX, SPDF, architecture views, cybersecurity risk assessment, and labeling produced or upgraded as needed.
- 03
Pen test + evidence
Independent pen test executed and findings closed before lock so the report ships clean inside the submission.
- 04
eSTAR-ready handoff
Every artifact delivered in the eSTAR attachment format; we stay on call through the review cycle.
What we see in Digital Therapeutics fda premarket cybersecurity package
The patterns we hit in this segment, this service, again and again.
Prescription/auth flow trusts client-side claims
App posts 'prescriber-approved' flag; cloud accepts it. Reviewer asks how that's enforced server-side; gap surfaces.
Content-delivery integrity not modeled
Tampered or substituted intervention content not in threat model. Reviewer asks what stops it.
Tenant isolation between health-system customers undocumented
Multi-tenant cloud with shared infra; isolation controls described in code, not evidenced in submission.
Mobile-app reverse-engineering not pen-tested
Pen test treats app as a black-box web client. DTx app should be tested under instrumentation; gap noted.
"Blue Goat Cyber helped us navigate our first end-to-end cybersecurity testing for our wearable medical device. Their communication was excellent, their timeline exceeded expectations, and their report helped us achieve FDA clearance without any additional questions. It was a truly seamless experience."
Standard FDA Premarket Cybersecurity Package deliverables
The same deliverables the parent FDA Premarket Cybersecurity Package service ships with - tuned to your digital therapeutics architecture.
- Secure Product Development Framework (SPDF)
- SBOM generation and vulnerability triage
- Threat modeling aligned to ANSI/AAMI SW96 + ISO 14971
- eSTAR-ready cybersecurity documentation
What lands in your eSTAR submission
Documents structured for the cybersecurity attachments of your submission - no reformatting on your side.
- Secure Product Development Framework (SPDF)
- SBOM generation and vulnerability triage
- Threat modeling aligned to ANSI/AAMI SW96 + ISO 14971
- eSTAR-ready cybersecurity documentation
Standards that apply
The Digital Therapeutics baseline, plus the call-outs that matter for fda premarket cybersecurity package in this segment.
Segment-specific call-outs
FDA 2026 final premarket guidance + SaMD considerations
Software-only products still need full SPDF + threat model + SBOM + pen test + architecture views. No 'lite' version for DTx.
ANSI/AAMI SW96
Threat-model framework reviewers will reference for SaMD.
What's not in scope
We scope tightly on purpose. These items are either out-of-scope by design or belong in a separate engagement - we'll tell you up front, not after kickoff.
- Quality system buildout (ISO 13485 / QMSR) - separate engagement
- Clinical or biocompatibility sections of the submission
- Regulatory filing on your behalf as agent of record
FDA Premarket Cybersecurity Package for Digital Therapeutics - FAQs
The questions buyers in this segment actually ask before scoping a fda premarket cybersecurity package engagement.
Go deeper on Digital Therapeutics and premarket
A practical, ungated buyer's guide for medical device manufacturers evaluating cybersecurity partners, what goes wrong, why it costs you, and what to demand from your next engagement. Aligned to the FDA February 2026 premarket guidance.
A practical, ungated guide to the threat modeling gaps that trigger FDA cybersecurity questions in 510(k), De Novo, and PMA submissions - and exactly how to close them before reviewers find them.
The most common cybersecurity deficiencies in 510(k), De Novo, and PMA submissions, what triggers each one and how to fix it before you file. Aligned to the FDA February 2026 final guidance and Section 524B.
Medical device cybersecurity should scale with device risk. Christian Espinosa argues why meeting only the Section 524B minimum leaves patients and submissions exposed.
VEX resources for medical device teams: a document guide, SBOM comparison, and common assessment mistakes, with evidence-based status and regulatory context.
Medical device cybersecurity for nanotech neurostimulation: a fictional STRIDE threat model linking controller risks, patient harms, controls, and testing.
Other engagements for Digital Therapeutics
Teams in this segment commonly bundle these alongside fda premarket cybersecurity package.
Keep going
Scope a FDA Premarket Cybersecurity Package engagement for your digital therapeutics program.
A 30-minute discovery call with Christian Espinosa, Founder and CEO, and Kristy Kennedy, VP of Sales.