MDUFMA I established broad responsibilities for OCP that cover the regulatory life cycle of drug-device, drug-biologic, and device-biologic combination products, and include product jurisdiction decisions and specific premarket review and postmarket processes. However, the primary responsibilities for scientific review and regulation of combination products remain in one of three product Centers – CBER, CDER, or CDRH – to which they are assigned by OCP. Specifically, the statute (503(g)(4)(B-F)) requires OCP to:
- Promptly assign a Center with primary jurisdiction for a combination product.
- Ensure the timely and effective premarket review of combination products by overseeing the timeliness of and coordinating reviews involving more than one Center.
- Ensure the consistency and appropriateness of postmarket regulation of combination products.
- Resolve disputes regarding the timeliness of premarket review of combination products.
- Review and update agreements, guidance documents or practices specific to the assignment of combination products.
OCP also serves as a focal point for addressing combination product issues raised by FDA reviewers and industry, and works with the Centers to develop guidance and/or regulations to clarify the regulation of combination products.
In addition, the Office of the Commissioner consolidated the product jurisdiction program in June 2003, giving OCP responsibility for FDA action on all RFDs submitted by industry in accordance with 21 CFR Part 3. This includes requests for classification and assignment of a particular product as a biological product, device, or drug, as well as requests for assignment of combination products.
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