Last week's video interview on medical device translations raised a question for at least one reader: What is a combination product?
Combination products, as the name implies, are products that share the attributes of two categories of products. In this article we will discuss the particular combinations of medical device and medicinal product.
FDA's definition of a combination product comes in four parts:
(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;Examples of combination products include prefilled syringes, alcohol swabs, inhaled insulin, coated artificial joints, and drug-eluting stents. Some of these are highly complex marvels of modern engineering while others are straight forward to manufacture.
(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products;
(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use; or
(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use.
Combination products are relatively new, and they present challenges in translation, packaging, and regulatory guidelines. For instance, industry, through groups like the Combination Products Coalition, is looking to shape the regulatory discussion and rule-making. As an aside, you have to just love the intro on their web site:
Are you tired of letting the regulatory environment lead you? Would you like to shape your regulatory environment?More resources and explanations can be found at the following sites:
- Emergo Group provides a hands-on view of combination products
- FDA's Combination Products web site features further definitions as well as information on regulatory guidelines and events.
- Implementing GMP for Combination Products: What Applies When? looks at the challenge of implementing a quality system that complies with Good Manufacturing Practices and Quality System Requirements.
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