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
FDA Guidance

FDA Software as a Medical Device (SaMD): A Practical Interpretive Guide

**FDA regulates Software as a Medical Device (SaMD)—software performing medical functions independently on general-purpose platforms like smartphones or cloud servers—under a risk-based framework, with exclusions for administrative tools, wellness apps, and clinical decision support meeting strict criteria. Companies must navigate multiple regulatory instruments including FDA's 2019 AI/ML guidance and 2023 predetermined change control plan guidance to determine premarket clearance requirements.**

10 min read Apr 22, 2026
Device Classification

In Vitro Diagnostic Device Classification: A Practical Guide to Getting It Right

**Summary:** Correct IVD classification determines your regulatory pathway—a Class I exemption takes weeks, Class II 510(k) takes 6–12 months, and Class III PMA takes 18–36 months and millions in costs. The FDA classifies IVDs under 21 CFR Parts 862–892 based on risk level, with each device assigned a product code and class that dictates required evidence, controls, and post-market obligations.

10 min read Apr 20, 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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