In the United States, a combination product is any product composed of a combination of a drug and a device, a drug and a biological product, a device and a biological product, or a drug, a device, and a biological product. Combination products are divided into three categories: single-entity, co-packaged, and cross-labeled combination products.
Single-entity combination products are comprised of two or more regulated components that are combined physically, chemically, or by other means. Co-packaged combination products are comprised of two or more separate products packaged together in a single package or as a unit. Cross-labelled combination products are drug, device, or biological products packaged separately that are intended for use only with an approved, individually-specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and, where upon approval of the proposed product, the labeling of the approved product would need to be changed.
As combination products entail drug, device, and biological products, understanding and complying with the regulations for each constituent part is critical to ensure compliance with the regulatory statutes. Kymanox helps our clients achieve compliance with 21 CFR Parts 3 and 4 by identifying areas where compliance gaps exist and recommending actions to be taken to ensure all necessary regulations are being met.