Classification turns on the device's clinical function. Components designed for bone fracture support or orthopedic correction go under 902110, while implantable artificial joints fall under 902131. Parts not specifically designed for those devices, and not covered by another named subheading, may fall under 902190. When the function is ambiguous, the heading notes and any applicable CBP binding rulings should guide the decision.

Both are FDA-regulated medical devices, but they follow different regulatory pathways based on risk class. Cardiac pacemakers (902150) are typically Class III devices requiring premarket approval, while many hearing aids (902140) are Class II and may clear through 510(k) or, for certain over-the-counter models, a separate OTC pathway established in recent years. Importers should confirm the specific device classification with FDA before entry.

Importers must ensure the foreign manufacturer is registered with FDA and that the device has the appropriate marketing authorization (510(k) clearance or PMA approval). CBP may request the FDA registration number and device listing information. For artificial joints subject to antidumping or other trade-remedy orders, additional certifications of origin may also be required.