1. SCOPE

The in vitro tests described in this chapter are designed to determine the biological response of cells to extracts of elastomers, plastics, and other polymeric materials used in packaging and delivery 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 a medical device (e.g., delivery devices) and for packaging that is considered a device-constituent part, users should refer to device-specific guidance such as FDA Guidance for Industry (1).