Classification And FDA Regulations: Medical Device, Pharma, and Combination Products

By Oliver Stauffer

Package integrity testing is regulated by the FDA and risk assessments determine the extent to which testing needs to occur. How the FDA regulates various product classes and the guidance documents driving regulatory enforcement varies from product to product. An important distinction is the difference between medical device, pharmaceutical products, and those considered combination products that ride the divide.

The FDA recognizes a medical device as any instrument, apparatus, machine, implant or other similar article which does not achieve its primary intended purpose through chemical action (purely a device). The moment the device includes a chemical component that actively reacts during its intended use, it becomes a combination product. A heart stent that is drug emitting is a combination product. A syringe without the liquid in it (just the components) is a device, and the moment it is designed to hold liquid, such as a pre-filled syringe, it becomes a combination product.