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
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

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