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
Device Classification

Classification of Digital Therapeutics: A Practical Guide to Determining Your FDA Regulatory Pathway

Digital therapeutics present a complex FDA classification challenge because software treatments don't fit traditional device categories. Choosing the correct classification pathway—Class I, II, or III—determines your premarket strategy, timeline, and budget, making it the most consequential early-stage regulatory decision.

10 min read Apr 23, 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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