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U.S. Department of Health and Human Services

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This Week In FDA History - Dec. 24, 2002

Photo with caption
  Metered-dose inhalers are classed as combination products because they use a medical device to deliver a drug dose.
December 24, 2002:
The FDA Office of Combination Products is formed. Mandated under the Medical Device User Fee and Modernization Act, this office oversees review of products that fall into multiple jurisdictions within FDA.

FDA in 2006

Combination products (medical products that combine drugs, medical devices, and/or biological products) are increasingly incorporating cutting-edge, novel technologies that hold great promise for advancing patient care. Drug-eluting stents and inhaled insulin are two breakthrough new products approved since the Office of Combination Products was established. Other combination products anticipated include novel
drug-delivery systems, drug-device combinations that are tailored to the way an individual's genetic inheritance affects the body's response to drugs, nanotechnology, gene therapy systems and many other diagnostic and therapeutic treatments. The Office of Combination Products expects these products to continue to become more complicated as new technologies emerge and existing technologies mature.