NAICS 33911 is a production-based classification, while FDA classifies devices by risk level (Class I, II, or III) under 21 CFR. A single NAICS 33911 subcategory can contain products spanning all three FDA risk classes, so importers must identify the specific FDA product code for each item to determine the correct regulatory pathway.

Surgical instruments (NAICS 339112) generally include precision hand-held tools used in operative procedures — scalpels, forceps, retractors — while surgical appliances and supplies (NAICS 339113) cover items like orthopedic braces, bandages, and patient-care disposables. The distinction matters because the two groups map to different HTS chapters with different duty rates and, in some cases, different FDA regulatory pathways.