SittuAI Editorial

FDA Regulatory Insights

Expert guidance on 510(k), De Novo, PMA submissions, and 21 CFR compliance. Written to help medical device companies navigate FDA regulatory pathways with confidence.

All Articles 510(k) Submissions De Novo Pathway PMA Submissions 21 CFR Compliance FDA Guidance Device Classification Post-Market
510(k) Submissions

Biocompatibility Testing for 510(k): A Complete Submission Guide

Biocompatibility testing for 510(k) submissions requires a risk-based evaluation framework per FDA's 2016 ISO 10993-1 guidance, not a fixed checklist—mistakes in scope, standard application, or data presentation commonly cause 3-6 month delays. Success depends on a robust Biological Evaluation Plan and Report that justify endpoint selection based on device contact type, duration, materials, and lifecycle factors.

11 min read May 16, 2026
510(k) Submissions

Writing a Compelling 510(k) Executive Summary: A Practical Guide

The 510(k) Executive Summary is a critical document that frames FDA reviewers' interpretation of your submission and directly impacts review timelines—a poorly organized summary triggers information requests that can delay clearance 90–180 days. This guide covers mandatory regulatory content, strategic framing, and common errors to distinguish summaries that accelerate clearance from those inviting scrutiny.

10 min read Apr 19, 2026

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