De Novo
6 articles
eSTAR Additional Information Response Playbook: How to Answer FDA Deficiency Letters Inside the eSTAR Workflow
Step-by-step playbook for responding to FDA Additional Information requests in eSTAR 510(k) and De Novo submissions — response table format, file naming, version control, section mapping, RTA vs substantive deficiencies, and traceability to original submission sections.
FDA AI-Enabled Device Predicate Mining Method: How to Identify, Evaluate, and Defend Your Predicate for 510(k) and De Novo
A methodical approach to mining FDA's AI-enabled device list and 510(k) database for predicate devices — covering technological characteristic extraction, public summary limitations, weak predicate argument avoidance, and a complete predicate evaluation matrix.
FDA ASCA Test Report Acceptance Package: How to Build a Bulletproof Evidence Package for 510(k) and De Novo Submissions
Step-by-step guide to building the ASCA evidence package for 510(k) and De Novo submissions — ASCA Summary Test Report, declaration of conformity, lab accreditation status check, scope matching, withdrawn/suspended lab risk, FDA questions, and submission rescue strategies.
FDA eSTAR Electronic Submission Template: Complete Guide to 510(k) and De Novo Submissions
Comprehensive guide to the FDA eSTAR electronic submission template for 510(k) and De Novo submissions — mandatory requirements since October 2023, template structure, section-by-section walkthrough, completeness verification, submission methods, and common mistakes to avoid.
Medical Device Startup Regulatory Strategy: From Concept to FDA Clearance (2026)
A practical regulatory strategy guide for medical device startups — covering FDA pathway selection, budget planning, Q-Sub pre-submissions, eSTAR templates, QMSR compliance, fundraising alignment, and the programs that accelerate market entry in 2026.
PMA vs 510(k): Differences, Requirements, and How to Choose the Right FDA Pathway
A detailed comparison of FDA's PMA and 510(k) pathways — clinical evidence requirements, review timelines, costs, post-market obligations, and a decision framework for choosing the right route to market.