Syringes, Needles, Catheters, Cannulae, and Similar Medical Instruments

FDA expects that sterile medical devices entering the US are manufactured under validated sterility assurance processes consistent with 21 CFR Part 820 (Quality System Regulation) or ISO 13485. While FDA does not require a specific sterility certificate at the port of entry, the importer of record is responsible for ensuring the device meets applicable standards, and FDA may request manufacturing records or sterility validation data during an import alert or examination.

Pre-filled syringes are typically regulated as combination products, with the primary mode of action determining the lead regulatory center (usually FDA's Center for Drug Evaluation and Research for drug-device combinations). Classification for tariff purposes generally follows the essential character of the combination; CBP has issued rulings treating pre-filled syringes as pharmaceutical preparations rather than medical devices in some cases, so a binding ruling is advisable.