Which regulatory body is primarily responsible for the approval of combination products in the United States?

The Food and Drug Administration (FDA) is the regulatory body primarily responsible for the approval of combination products in the United States. Combination products are those that include two or more regulated components, which can be a combination of a drug, device, and/or biological product. The FDA has established a specific office, the Office of Combination Products (OCP), to oversee the review and regulation of these products, ensuring that they meet the appropriate safety and efficacy standards before they can be marketed.

This regulatory framework is essential because combination products often present unique challenges in terms of their evaluation, given that they can embody the characteristics of more than one type of product. The OCP coordinates the review process across different centers within the FDA that specialize in either drugs, devices, or biological products, ensuring that all relevant perspectives are considered during the approval process.

Other agencies mentioned, such as the Environmental Protection Agency (EPA), the National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC), do not have the primary responsibility for the review and approval of combination products. Their focuses are more aligned with environmental health, biomedical research, and public health, respectively. Thus, the FDA's role is unparalleled when it comes to the oversight of combination products.