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
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

Ready to accelerate your FDA submission?

SittuAI drafts 80% of your 510(k), De Novo, or PMA documentation. Consultants validate it. You submit faster.

Get Started — It's Free