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  1. FDA-TRACK: Agency-wide Program Performance



The Office of Combination Products (OCP) serves as a focal point for combination product (drug-device, biologic-device, drug-biologic, or drug-device-biologic products) issues for agency reviewers and industry. The office is responsible for ensuring the prompt assignment of combination products (drug-device, biologic-device, drug-biologic, or drug-device-biologic products) to FDA Centers, the timely and effective premarket review of such combination products, and consistent and appropriate postmarket regulation of these products. Explore the progress OCP is making towards its performance goals below.

I. Request for Formal Designation (RFD) Processing Measures

II. Informal Requests of Product Designation Processing Measures

Download OCPP OCP Dataset

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.

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