09.16.14
The U.S. Food and Drug Administration (FDA) defines a combination product as: A product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.1 Regulated by FDA’s Center for Biologics Evaluation and Research, biological products include vaccines, blood products, and gene therapies. Most combination products, however, incorporate a drug and a medical device. Common examples include drug-eluting stents, metered dose inhalers and prefilled syringes.
The first step to ensuring compliance is to determine the regulations with which the combination product and its manufacturing process must comply, and thus which agency center will be assigned lead jurisdiction. In many regions, including the United States and Europe, this will depend on the product’s “primary mode of action”—basically whether the drug or the device aspect of the combination product provides the main therapeutic function.2
FDA’s definitions of a medical device and a drug share the following characteristics:3
The first step to ensuring compliance is to determine the regulations with which the combination product and its manufacturing process must comply, and thus which agency center will be assigned lead jurisdiction. In many regions, including the United States and Europe, this will depend on the product’s “primary mode of action”—basically whether the drug or the device aspect of the combination product provides the main therapeutic function.2
FDA’s definitions of a medical device and a drug share the following characteristics:3
- Intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animal (devices also can be intended for the diagnosis of other conditions besides disease);
- Intended to affect the structure or any function of the body of man or other animals; and
- Recognized in the official National Formulary, or the United States Pharmacopeia, or in any supplement to them (drugs also can be recognized in the official Homoeopathic Pharmacopoeia of the United States).
- The term drug refers to an article, while the term device refers to “an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part or accessory;” and
- A drug achieves its primary intended purposes “through chemical action within or on the body of man or other animals” and “is dependent upon being metabolized for the achievement of its primary intended purposes.” None of this is true for the FDA definition of a device.