Focused FDA Mock Review Module
For medical devices supported by clinical data, clinical studies, literature evidence, or postmarket evidence, Panabistics reviews the clinical 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 |
|---|---|
| Clinical evidence strategy | Whether the overall clinical-evidence approach is appropriate for the device, proposed indications, claims, risks, and submission pathway. |
| Need for clinical evidence | Whether the package clearly explains why clinical evidence is required, limited, or not required. |
| Literature support | Whether literature evidence is relevant, current, appropriately selected, and applied consistently within the submission. |
| Study design | Whether the clinical study design, population, comparators, endpoints, follow-up, and analysis approach are appropriate. |
| Endpoints | Whether primary and secondary endpoints are clinically meaningful, clearly defined, and aligned with the proposed claims. |
| Statistical rationale | Whether sample size, analysis populations, statistical methods, and handling of missing data are adequately justified. |
| Safety evidence | Whether adverse events, device deficiencies, safety signals, and benefit-risk considerations are clearly evaluated. |
| Predicate and comparison strategy | For 510(k) submissions, whether comparisons and supporting rationales are appropriately framed and supported where applicable. |
| Postmarket evidence | Whether relevant postmarket, registry, complaint, or real-world evidence is appropriately considered where applicable. |
| Submission consistency | Whether the clinical evidence aligns with the device description, proposed indications, labeling, risk management file, performance evidence, and eSTAR content. |
Deliverables
FDA-style questions and deficiencies focused on likely clinical evidence 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 clinical evidence package before submission.
Support to revise documents, address gaps, and prepare stronger FDA-facing clinical evidence.
Audience
This service does not replace FDA review, clinical study conduct, biostatistics, medical writing, 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 clinical evidence package. We will respond within 24 business hours.