Focused FDA Mock Review Module
For SaMD, firmware-controlled devices, mobile medical apps, embedded software, and other software-intensive medical devices, Panabistics reviews the software documentation 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 |
|---|---|
| Software description | Whether the software scope, intended use, and functional description are clear and aligned with the device and submission pathway. |
| SOUP / Third-Party Software | Whether software of unknown provenance and other third-party software components are identified, characterized, and supported by appropriate risk controls and documentation. |
| Architecture | Whether software architecture diagrams, modules, interfaces, and data flows are adequate and consistent with the device design. |
| SDLC | Whether the software development lifecycle is described, controlled, and supported by credible process evidence. |
| Verification and validation | Whether software V&V activities, protocols, results, and traceability support the claimed software functionality and safety. |
| Cybersecurity linkage | Whether software documentation aligns with cybersecurity risk assessment, controls, and testing where applicable. |
| Labeling | Whether software-related instructions, warnings, and user-facing content are supported by the software documentation. |
| eSTAR consistency | Whether software content aligns with system description, risk management, cybersecurity, labeling, and test evidence. |
| SaMD documentation | Whether SaMD-specific documentation meets FDA expectations for classification, intended use, and evidence structure. |
| Change control | Whether software change management, version control, and update processes are adequately described and controlled. |
Deliverables
FDA-style questions and deficiencies focused on likely software documentation 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 software documentation package before submission.
Support to revise documents, address gaps, and prepare stronger FDA-facing software evidence.
Audience
This service does not replace FDA review, software 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 software documentation package. We will respond within 24 business hours.