1. SCOPE

This chapter describes the Systemic Injection Test designed to determine the biological response of animals to elastomers, plastics, and other polymeric materials or their extracts used in packaging systems for drugs and packaging of combination products regulated by the US FDA's Center for Drug Evaluation and Research (CDER). For medical devices and combination products regulated as medical devices (e.g., delivery devices) and for packaging that is considered a device-constituent part, users should refer to additional device-specific FDA Guidance for Industry (1).