New: Toy Safety Regulation (EU) 2025/2509 — applies from 1 Aug 2030, with digital product passport obligations.

Read the analysis →
Regulation database
21 CFR Part 814In force

21 CFR Part 814 — Premarket Approval of Medical Devices (FDA — Food and Drugs)

21 CFR part 814 SaveOfficial source

Summary

US eCFR 21 CFR Part 814 (Premarket Approval of Medical Devices) — FDA — Food and Drugs.

Scope

US Code of Federal Regulations part — reference resource for fda — food and drugs.

Expert analysis

Our compliance experts are preparing a detailed analysis for this regulation. Check back soon.

Want this analysis for your product?

Enter your product features once — ComplyMatrix maps all applicable EU regulations, obligations and testing requirements in minutes.