Most articles under this heading are regulated as medical devices under the Federal Food, Drug, and Cosmetic Act. Foreign manufacturers must be registered with FDA, and devices must be listed. Depending on the device class, a 510(k) clearance or premarket approval may be required before the product can be legally marketed in the US. FDA may detain shipments at the port of entry if these requirements are not met.

Syringes — devices with a plunger mechanism for injecting or withdrawing fluids — fall under 901831. Catheters, cannulae, and tubular instruments designed for insertion into body cavities or vessels without a plunger mechanism fall under 901839. Combination devices such as pre-filled syringes with catheter tips require review of the essential character and any applicable FDA product codes.