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U.S. Department of Health and Human Services

Drugs

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Combination Products: One plus one, two or three, equals one

 

When an application for a drug, biologic or device enters the FDA it’s triaged to the appropriate area for review. What happens if the potential product is a combination of the two, or all three -- in steps the Office of Combination Products (OCP).
 
Let’s talk about the basics. Combination products are comprised of two or more different products: a drug and a device; a biologic and a device; a drug and a biologic; or a drug, biologic and device. These products also include combinations that are physically, chemically or otherwise mixed and produced as a single product; two or more products contained in a single package; or separate products that are cross-labeled to be used together.  Examples include bandages that have an antibiotic coating, or bandages packaged with a tube of antibiotic ointment; pre-filled syringes; stents that slowly release a drug; or lasers and a photosensitive drug.
 
The roles of the Office of Combination Products include: 
 
  • Serving as a focal point for combination product issues for agency reviewers and industry.
  • Developing guidance and regulations to clarify the regulation of combination products.
  • Assigning an FDA center to have primary jurisdiction for review of both combination and single entity (i.e., non-combination) products where the jurisdiction is unclear or in dispute.
  • Ensuring timely and effective premarket review of combination products by overseeing the timeliness of and coordinating reviews involving more than one agency center.
  • Ensuring consistency and appropriateness of post market regulation of combination products.
  • Resolving disputes regarding the timeliness of premarket review of combination products.
  • Updating agreements, guidance documents, or practices specific to the assignment of combination products.
 
For additional information about combination products, including formal and information jurisdiction questions, general considerations and post-market issues, contact: combination@fda.gov.
 
CDER Small Business Combination Products Webinar - February 28, 2012