FDA regulates sterilizers intended for medical or surgical use as medical devices, requiring manufacturer registration and device listing. Sterilizers marketed solely for laboratory research use may not require the same premarket clearance, but the intended use must be clearly documented at entry to support the correct regulatory pathway.

The sterilization method affects both the regulatory classification and facility requirements. Ethylene oxide sterilizers, for example, are subject to EPA air-emission regulations in addition to FDA device requirements, while hydrogen peroxide plasma units may have specific material-compatibility limitations that affect their cleared indications. Importers should confirm that the technology matches the intended use claims in the device registration.