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

Predetermined Change Control Plans (PCCP) for AI/ML Medical Devices: An Interpretive Guide

**Summary:** The FDA's December 2024 PCCP guidance allows AI/ML medical device makers to pre-approve post-market algorithm changes without new submissions, provided they submit detailed plans describing anticipated modifications, implementation methods, and performance standards. Common deficiencies include vague change descriptions, inadequate performance metrics, and insufficient risk documentation.

11 min read Oct 27, 2026
FDA Guidance

Real-World Evidence for Medical Device Regulatory Decisions: An Interpretive Guide

The FDA now accepts real-world evidence (RWE)—data from clinical practice outside controlled trials—to support device approvals, expansions, and postmarket requirements under an evolving regulatory framework. Companies must ensure their real-world data is fit for purpose, methodologically rigorous, and properly documented to meet FDA's credibility standards across the device lifecycle.

11 min read May 8, 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

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