Combination products may include which of the following?

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Combination products are defined by their incorporation of two or more regulated components, which can include a drug, device, and/or biological product. The correct answer reflects the understanding that a combination product can consist of a device and a prescription medication, where each component retains its regulatory identity while working together for a specified use.

In the case of a device and prescription medication, such as a drug-eluting stent, the device provides a delivery method for the medication, illustrating how these two types can effectively combine to enhance the therapeutic effect.

The inclusion of only a drug and a biological product does not encompass the broader range of combination products, as it rules out the potential pairing of devices with drugs or biologicals. The statement regarding a contact lens and a cosmetic also denotes a mix of regulated products, but these do not fall under the traditional regulatory definitions for combination products since they serve distinctly separate functions without a synergistic effect. Lastly, a single type of regulated product contradicts the very nature of combination products, which inherently involves multiple classifications working together. Thus, the most comprehensive understanding of combination products is reflected in the pairing of a device and a prescription medication.

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