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How should I handle combination products from an FDA perspective?

A combination product is a product comprised of two or more regulated components (drug/device or biologic/device) that are combined as a single entity or is a product labeled for use with a specified drug, device, or biologic where both are required to achieve the intended use, indication, or effect.

To ease the regulatory burden of industry, FDA has established Intercenter agreements which establishes the lead FDA Center for review and oversight of certain categories of products. Intercenter agreements with CDRH are referenced below.

Intercenter Agreement Between the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health.
http://www.fda.gov/oc/ombudsman/bio-dev.htm

Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health.
http://www.fda.gov/oc/ombudsman/drug-dev.htm

Some combination products involve cutting edge, novel technologies that raise not only unique scientific and technical questions, but also regulatory challenges related to where and how they should be regulated in order to ensure adequate and consistent regulatory oversight. The Office of Combination Products assigns review responsibility for combination products. The Office is also responsible for designating the component of FDA with primary jurisdiction for the premarket review and regulation of any product requiring a jurisdictional designation.

Additional information regarding combination products can be found at the following website: