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Compliance In Focus
Posted by John Lehmann on Wed, Feb 22, 2012

What Exactly Are Device-Drug Combination Products?

The area of combination products is an exciting expanse of potential innovation and discovery for both the medical device and drug industries. But what exactly are combination products? According to 21 CFR 3.2(e), they are defined as:

  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;
  2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug 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, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose;
  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, indication, or effect.

Some of the challenges that may present in the area of combination products include understanding the classification, and jurisdiction of these products. Overall, device-drug products may have oversight from different departments depending on their make-up. The Office of Combination Products (OCP) acts as an “umbrella” and one of its responsibilities is assigning combination products to agency centers. These agency centers include:

• CDRH – Center for Devices and Radiological Health
• CDER – Center for Drug Evaluation and Research
• CBER – Center for Biologics Evaluation and Research

Assignment to these agency centers is dependent upon the primary mode of action of the combination product. As of 2005, the primary mode of action is defined as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product.”

The FDA’s website offers great resources on this matter including, examples of combination products, premarket review and post-market regulation, reporting of adverse events, and other useful information.

Interestingly enough, MD+DI recently released an article about this topic. In the article, a medical device and combination products expert, Mark Kramer, answers these five questions:

  1. What is a combination product?
  2. How does FDA determine the assignment of a combination product to a lead Agency Center?
  3. hat are the most important things to accomplish in a Request for Designation?
  4. What kind of marketing applications are submitted for a combination product?
  5. What are FDA’s expectations for key post-marketing requirements for combination products?

Check out the answers in the article, and the FDA’s website for combination products. Do you have any unanswered questions regarding combination products? Feel free to comment below!

Topics: Office of Combination Products, Combination Products, FDA, MD+DI


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