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?

21a

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.

Yes

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What of the following applies?

21b

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:

nasopharynx (top),
oropharynx (center, behind the mouth)
laryngopharynx (bottom)

The device, or its products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose

The device achieves its intended purpose in the stomach or lower gastrointestinal tract and it, or its products of metabolism, are systemically absorbed by the human body

The device is applied to the skin or the device is applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities

Any other case

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