Is your device composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body?

 
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Body orifice means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

What of the following applies?

 
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A metabolic product is a compound produced by the cells and is excreted to the extracellular medium. It could be produced in the primary metabolism, e.g. carbon dioxide, ethanol, acetate, or lactate, or a more complex one, e.g. a secondary metabolite or a heterologous protein secreted to the extracellular medium.

The pharynx is the throat; the musculomembranous cavity, about 5 inches (12.5 cm) long, behind the nasal cavities, mouth, and larynx, communicating with them and with the esophagus. It includes many individual structures and may be divided into three areas: