De Novo
10 articles
FDA Safer Technologies Program (STeP) for Medical Devices: Complete Regulatory Guide
A comprehensive guide to the FDA Safer Technologies Program (STeP) in 2026, including eligibility criteria, safety-innovation factors, Q-Submission application steps, benefits, and TAP pilot updates.
FDA Medical Device Product Codes: Analysis of 7,075 Classification Codes
A data-driven analysis of the FDA Medical Device Classification Database. We parse 7,075 product codes by class, specialty panel, and submission type.
FDA De Novo Database Teardown: Grants by Year, Panel, and Pathway (1997-2025)
A deep quantitative teardown of the FDA De Novo database. Analysis of annual grant trends, review timelines, advisory panel distributions, and the strategic cost-benefit of the pathway.
Medical Device Accessory Classification: EU MDR and FDA Pathways
How accessories are classified separately from parent devices under EU MDR Article 2(2) and FDA 513(f)(6), with examples, MDCG 2021-24 Rev.1 updates, and FDA's 2025-2026 reclassification initiative.
eSTAR Additional Information Response Playbook for FDA Deficiency Letters
Playbook for answering FDA Additional Information requests in eSTAR 510(k) and De Novo submissions, covering response tables, file naming, version control, section mapping, and traceability.
FDA AI-Enabled Device Predicate Mining for 510(k) and De Novo
Method for mining FDA AI-enabled device and 510(k) databases to identify predicates, compare technology, avoid weak arguments, and build a defensible predicate matrix.
FDA ASCA Test Report Acceptance Package for 510(k) and De Novo
Step-by-step guide to ASCA evidence packages for 510(k) and De Novo submissions, including summary test reports, declarations, lab accreditation, scope matching, and FDA questions.
FDA eSTAR Electronic Submission Template: Complete Guide to 510(k) and De Novo Submissions
Guide to FDA eSTAR electronic submission templates for 510(k) and De Novo, including mandatory use, template structure, completeness checks, submission methods, and common mistakes.
Medical Device Startup Regulatory Strategy: From Concept to FDA Clearance (2026)
Build a startup regulatory strategy covering FDA pathway selection, budgets, Q-Subs, eSTAR templates, QMSR readiness, fundraising alignment, and 2026 accelerator programs.
PMA vs 510(k): Differences, Requirements, and How to Choose the Right FDA Pathway
Compare FDA PMA and 510(k) pathways by evidence requirements, review timelines, costs, post-market duties, and decision criteria for US market entry.