Focused FDA Mock Review Module

FDA Bench & Performance Evidence Mock Deficiency Review

For medical devices relying on bench, analytical, or performance testing to support substantial equivalence or safety and effectiveness, Panabistics reviews the performance evidence package against FDA expectations and produces a mock deficiency letter identifying likely review questions before submission.

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Bench & Performance Module

Bench & Performance Evidence Mock Deficiency Review

The review focuses on whether the performance evidence is complete, credible, statistically sound, and consistent with the device design, intended use, labeling claims, risk management file, and eSTAR content.

Review Scope

Bench & Performance Review Scope

Area Reviewed	What We Assess
Test rationale	Whether the testing strategy is justified, complete, and aligned with device intended use and submission pathway.
Protocols	Whether test protocols are well-defined, reproducible, and appropriate for the device and claimed performance.
Acceptance criteria	Whether acceptance criteria are predefined, scientifically justified, and linked to device requirements.
Sample size	Whether sample sizes and test units are adequate to support the conclusions presented.
Bench testing	Whether bench and engineering tests support device safety, design, and performance claims.
Performance testing	Whether performance studies demonstrate the device meets intended functional and safety requirements.
Statistical analysis	Whether statistical methods, analyses, and conclusions are appropriate and correctly applied.
Predicate comparison	Whether 510(k) performance comparisons to the predicate are credible, complete, and appropriately scoped.
Reported results	Whether test reports, summaries, and conclusions are consistent with raw data and submission claims.

Deliverables

Bench & Performance Mock Review Deliverables

Mock FDA Performance Deficiency Letter

FDA-style questions and deficiencies focused on likely bench and performance evidence review concerns.

Performance Deficiency Register

Excel-style tracker with issue, source, severity, regulatory basis, recommended fix, and owner field.

Executive Readiness Memo

Clear readiness summary with go, conditional-go, or not-ready recommendation.

Remediation Roadmap

Prioritized steps to strengthen the performance evidence package before submission.

Optional Remediation Support

Support to revise documents, address gaps, and prepare stronger FDA-facing performance evidence.

Audience

Who Should Consider This Review

FDA 510(k) submissions with bench or performance testing
FDA De Novo submissions with performance evidence
eSTAR submissions with test reports and summaries
IVD and non-IVD devices with analytical performance data
Submissions with predicate performance comparisons
Performance packages after lab or CRO testing
Responses to FDA performance questions
Final submission readiness checks before filing

What This Service Is Not

This service does not replace FDA review, laboratory testing, test method development, statistical consulting, 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.

Available Independently or as Part of the Full eSTAR Review

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.

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Full eSTAR Mock Review Cybersecurity Software Documentation Human Factors & Usability Risk Management Labeling & Claims Clinical Evidence

Request a Review

Request a Bench & Performance Mock Deficiency Review

Tell us about your device, submission pathway, and performance evidence package. We will respond within 24 business hours.

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