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

Device Modifications and the 510(k) Threshold: A Practical Interpretive Guide

Manufacturers of 510(k)-cleared medical devices must determine whether modifications require a new submission or can be documented internally—getting this wrong risks regulatory action or unnecessary delays. FDA's 2017 guidance provides a decision framework based on whether changes "could affect" device safety or effectiveness, placing the burden on manufacturers to document their analysis regardless of outcome.

10 min read May 4, 2026

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