FDA-TRACK: Office of the Chief Medical Officer - Office of Combination Products Dashboard
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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 FDA-TRACK OCMO Office of Combination Products Dataset
Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.