Focused FDA Mock Review Module
For connected devices, SaMD, mobile medical apps, Bluetooth-enabled devices, firmware-controlled devices, cloud-connected systems, and other cyber devices, Panabistics reviews the cybersecurity evidence package against FDA expectations and produces a mock deficiency letter identifying likely review questions before submission.
Available Now. Expert-led, reviewer-style regulatory consulting.
Review Scope
| Area Reviewed | What We Assess |
|---|---|
| Cyber device applicability | Whether FDA cybersecurity requirements apply and whether the rationale is clear. |
| Secure Product Development Framework | Whether the SPDF is adequately described and supported by the submitted documentation. |
| Threat modeling | Whether threats, assets, interfaces, data flows, attack surfaces, and trust boundaries are clearly identified. |
| Cybersecurity risk assessment | Whether cybersecurity risks, controls, residual risks, and patient impact are appropriately connected. |
| SBOM | Whether the SBOM is usable, current, and aligned with the software architecture and third-party components. |
| Vulnerability management | Whether postmarket monitoring, vulnerability intake, triage, remediation, and update processes are credible. |
| Cybersecurity testing | Whether the testing supports the claimed cybersecurity controls and device risk profile. |
| Architecture and data flow | Whether diagrams clearly show interfaces, communication paths, trust boundaries, and update mechanisms. |
| Labeling and IFU | Whether cybersecurity instructions are adequate, user-appropriate, and not overclaimed. |
| eSTAR consistency | Whether cybersecurity content aligns with software, risk management, labeling, system description, and test evidence. |
Deliverables
FDA-style questions and deficiencies focused on likely cybersecurity review concerns.
Excel-style tracker with issue, source, severity, regulatory basis, recommended fix, and owner field.
Clear readiness summary with go, conditional-go, or not-ready recommendation.
Prioritized steps to strengthen the package before submission.
Support to revise documents, address gaps, and prepare stronger FDA-facing evidence.
Audience
This service does not replace FDA review, cybersecurity testing, penetration testing, software validation, legal advice, or the sponsor’s responsibility for submission content. It is an independent regulatory and submission-readiness review designed to identify likely FDA review concerns before submission. Panabistics does not represent FDA and does not guarantee clearance or approval.
This focused module can be commissioned independently or included as an applicable component of a broader Full eSTAR Mock Deficiency Review when the substantially complete submission package is available.
Explore the Full eSTAR Mock ReviewSelect a focused review module or explore the Full eSTAR Mock Deficiency Review for a broader submission-readiness assessment.
Request a Review
Tell us about your device, submission pathway, and cybersecurity package. We will respond within 24 business hours.