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Does OCP review marketing applications for combination products?

April 26, 2017applications combination Marketing ocp products review

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Does OCP review marketing applications for combination products?

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No. OCP does not review marketing applications for combination products. OCP assigns a lead Center (CBER, CDER or CDRH) that will have primary jurisdiction for the premarket review and regulation of a combination or single-entity product, and develops policy for combination product regulation. OCP is also responsible for ensuring timely and effective premarket review of combination products by overseeing the timeliness of and coordinating reviews involving more than one agency center. In addition, OCP is available as a resource to industry and agency reviewers to help facilitate the review process, to help clarify and/or develop appropriate regulatory pathways, or to provide any other assistance as appropriate to OCP’s mission.