FDA Mock Deficiency Review - eSTAR, 510(k) & De Novo
Panabistics reviews your submission package the way a skeptical FDA reviewer may approach it, identifying likely deficiencies, weak rationales, inconsistent evidence, and missing documentation before you submit.
Expert-led, reviewer-style regulatory consulting, not a generic checklist.
Umbrella Service
A completed eSTAR is not always a submission-ready package. The Full eSTAR Mock Deficiency Review is a reviewer-oriented challenge of a substantially complete FDA submission package. Panabistics assesses whether the applicable evidence areas are complete, credible, traceable, and internally consistent before the package is submitted to FDA.
The review is tailored to the device type, submission pathway, technology, claims, and available documentation. Depending on the device, the review may include cybersecurity, software documentation, human factors and usability, risk management, labeling, bench and performance evidence, and clinical evidence.
Important: Not every review module applies to every device. The Full eSTAR review is scoped based on the applicable FDA requirements and the evidence package provided by the sponsor.
Part of the Panabistics Regulatory Readiness Stress Test service line
The FDA Mock Deficiency Review is the FDA-focused service within Panabistics’ broader Regulatory Readiness Stress Test offering. It is designed to identify likely FDA questions, weak evidence, unsupported claims, traceability gaps, cybersecurity documentation issues, software documentation weaknesses, labeling inconsistencies, and submission-readiness risks before FDA review.
Explore All Readiness Stress TestsDeliverables
FDA-style questions and deficiencies written in the tone and structure of a reviewer challenge.
A practical issue tracker identifying the deficiency, source document, severity, regulatory basis, owner, and recommended remediation.
Assessment of whether claims, risks, controls, test evidence, labeling, software documentation, and submission content align.
A clear readiness assessment identifying high-risk gaps, moderate concerns, and items suitable for cleanup before submission.
Practical next steps to strengthen the package before FDA review.
Support to revise documents, close gaps, and prepare a stronger submission package.
Focused Modules
Each focused review module can be commissioned independently, combined with other modules, or included as an applicable component of the Full eSTAR Mock Deficiency Review.
Reviewer-style cybersecurity package review for connected devices, SaMD, mobile apps, and firmware-controlled devices.
View Review ScopeReviewer-oriented challenge of software documentation against FDA submission expectations.
View Review ScopeReview of usability and human factors evidence for submission-readiness, task coverage, labeling linkage, and likely FDA questions.
View Review ScopeAssessment of risk management file consistency, traceability, risk controls, residual risk, and submission alignment.
View Review ScopeReview of IFU, package labeling, app screens, symbols, UDI, cybersecurity instructions, and promotional claims against supporting evidence.
View Review ScopeChallenge of performance testing rationale, protocols, acceptance criteria, sample size, and reported results.
View Review ScopeReviewer-oriented challenge of clinical evidence strategy, study rationale, literature support, endpoints, safety evidence, and support for the proposed indications and claims.
View Review ScopeAdditional review areas available by request: Biocompatibility, Sterilization & Shelf-Life, Electrical Safety & EMC, Predicate / Substantial Equivalence, AI/ML SaMD, IVD evidence, packaging, UDI, and postmarket / PMS-related documentation.
Audience
This service is designed for medical device companies preparing or reviewing:
This service does not replace FDA review, required testing or validation, legal advice, or the sponsor’s responsibility for the completeness and accuracy of the 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.
Request a Review
Tell us about your submission pathway, device type, and timeline. We will respond within 24 business hours to discuss scope and next steps.
Kitchener-Waterloo, Ontario, Canada
Within 24 business hours