Biomedix 510(k) eSTAR Submission Series
Video 1 – Navigating the 510(k) eSTAR Submission Process
Why the 510(k) eSTAR template is now the FDA’s standard for electronic submissions— and how it reshapes the preparation and review process. Perfect for startups, regulatory professionals, and medtech teams aligning with FDA expectations.
Video 2 – Complete eSTAR Template Walkthrough (v5.5)
A complete page-by-page walkthrough of the FDA’s eSTAR template (v5.5), covering admin inputs, labeling, testing, checklists, and everything needed for a compliant 510(k) submission.
Video 3 – Part 1: Device Description in eSTAR
How to create a clear, accurate Device Description—the foundation of every 510(k). Includes structure, content expectations, and how the FDA evaluates completeness.
Video 3 – Part 2: Substantial Equivalence in eSTAR
Substantial Equivalence (SE) is the core justification behind every 510(k). This episode explains how to present SE claims, predicate comparison, and common FDA reviewer pitfalls.
Video 4 – Predicate Selection Strategy
How to choose a strong predicate — one of the most critical strategic decisions in a 510(k). Covers pitfalls, FDA expectations, and optimizing review outcomes.
Video 5 – Labeling & Performance Bench Testing in eSTAR
Covers two essential submission components: labeling requirements and performance bench testing, including documentation quality and FDA review expectations.
Video 6 – Biocompatibility, Animal, and Clinical Testing in eSTAR
This episode clarifies how to address some of the most scrutinized evidence in a 510(k), including biocompatibility strategies, animal study documentation, and clinical evidence alignment.
Video 7 – Sterilization & Shelf Life in eSTAR
A deep dive into two highly technical eSTAR modules: sterilization validation and shelf-life testing. Includes documentation structure, common reviewer issues, and how to ensure a complete submission package.
Video 8 – Software Documentation, Cybersecurity & EMC in eSTAR
This episode addresses three of the most complex areas of FDA review: software documentation requirements, cybersecurity expectations, and electromagnetic compatibility (EMC) testing and reporting.
Video 9 – Risk Management & QMS Integration in eSTAR
This episode ties together risk management, design controls, and QMS alignment— showing how these elements directly influence 510(k) completeness and FDA review success under the eSTAR framework.