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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.

Each FDA-TRACK program area collects, analyzes, and reports its performance measures and results. Explore the progress OCP is making towards it's performance goals below.

I. Request for Formal Designation (RFD) Processing Measures


II. Informal Requests of Product Designation Processing Measures

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