Combination Products

Combination Products

Combination products are a merger of any drug and any device, a particular biological product with any medication, devices with  organic products, or a combination of the three- natural products, the drugs, and appliances. Food and Drug Administration (FDA) is a body set to protect the health being of the public and ensure that its people are safe by providing all human and veterinary drugs, biological products, and devices are safe and reliable (Kelly, 2020).

Determining a combination Product for a company requires an insight into the FDA’s definitions of what should be a combination product and what should not. FDA, through the Food and Drugs federal regulations Act (FDC), there are four clear definitions of what a combination product is and is not. Using these definitions, determining the category of the product becomes more natural — the breakdown of the components of the product and a clear understanding of what makes up the product.

If the product falls in the category of combination products, the first thing is to ensure that the product is viable and will perform well. Secondly, the primary mode of action (PMOA), which under the FDA, is to identify which one provides a more significant contribution with regards to the overall functioning of this combination product? In the case whereby the PMOA is unclear, the FDA offers help through its minor agencies. The product jurisdiction needs a clear establishment to identify the position in which the product falls. If the product jurisdiction is vague, a Request for Designation (RFD) through the Office of the Combination Products (OCP) (Kelly, 2020). Another step is the pre-approval application submission to approve the product. Product testing is a must to ensure that the product meets all its requirements and does not harm any user.

References

Kelly, J. (2020). [online] Northeastern.edu. Available at: https://www.northeastern.edu/cri/assets/uploads/2015/08/Combination-Products.pdf [Accessed 4 Feb. 2020].

Moodley, J., & Coulter, I. (2008). U.S. Patent Application No. 11/663,832.