The FDA Guidance for Industry Titled “Current Good Manufacturing Practice Requirements for Combination Products (January 2017)” defines a combination product as “a product composed of two or more types of medical products (i.e. a combination of a drug, device, and/or biological product with another).”   There are three types of combination products: single entity, co-packaged and cross labeled.

A single entity combination product has at least two components (i.e. drug/device, biologic/device, drug/biologic or all three) that are chemically or physically combined to form a single entity.  Examples of single entity combination products would be a prefilled syringes or a drug coated surgical implant.

A co-packaged combination product has at least two components packaged together as a single unit. Examples of co-packaged combination products are surgical kits and drug products packaged with infusion sets.

With a cross labeled combination product, each component is packaged separately and is intended only for use with an approved second product.   An example of a cross labeled combination product would be a light activated drug requiring a light emitting device.

Pine Lake Laboratories has experience with analytical methodologies to support all forms of combination products.

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