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The Revised Authoritative Guide To Vaccine Legal Exemptions

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Why a chapter on medical devices in a book on pharmaceutical information? The device and pharmaceutical industries, along with their attendant information needs, have for the most part operated independently of each other. However, the trend toward so-called combination products—comprising two or more drug, medical device, or biologic components—is bringing the device and pharmaceutical industries much closer together, often via formal licenses or partnerships. The Food and Drug Administration (FDA), with separate centers for regulating drugs and devices, created the office of combination products

(OCP) in 2003 to more effectively deal with the intersecting regulatory aspects of such products.

What exactly is a medical device? The FDA definition is:

'' ... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.'' [1. Federal Food, Drug and Cosmetic Act, Section 201. http://www.fda.gov/cdrh/ consumer/product.html#1 (accessed October 2005).]

Medical devices can be anything from thermometers to artificial hearts to in-home pregnancy test kits. Devices, unlike drugs, are not dependent on a chemical action. Device inventors are more concerned with anatomy—skin, internal organs, tissue—and the compatibility of the device both within and on the surface of the body.

As noted above, a device may include a drug or biological component. The FDA provides a detailed definition of a combination product, the most general being:

"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.'' [2. http://www.fda.gov/oc/combination/definition. html (accessed October 2005).]

Examples of combination products include drug-eluting stents, implantable insulin pumps, and skin patches that deliver protein therapies. A biological product is a virus, vaccine, therapeutic serum, toxin or antitoxin, blood, blood component or derivative, or allergenic that prevents, treats, or cures diseases or injuries to humans. Biological products include viral vaccines, human blood and plasma, and interferons and erythropoietins.

The recent advances in information technology and biotechnology, along with the development of combination products, have added a new dimension to the definition of what constitutes a medical device and have moved the device industry into new, unfamiliar territory. The evolving market requires a symbiotic relationship between biomedical engineers and other disciplines, such as information technology, biotechnology, and pharmaceuticals. The device industry also provides medical applications for a wide range of other technologies, including tissue engineering, biomaterials, genomics, and nanotechnology.

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