Introduction
The U.S. Food and Drug Administration (FDA) established the Office of Combination Products (OCP) in 2002, as mandated by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The OCP's core mission is to ensure the prompt assignment of combination products to appropriate FDA Centers, facilitate timely and effective premarket reviews, and maintain consistent and appropriate postmarket regulation. This report outlines the OCP's performance and achievements throughout FY 2022, covering key areas such as product classification, premarket review processes, and postmarket oversight.
Key Activities and Accomplishments
In FY 2022, the OCP focused on several critical areas:
- Prompt Assignment of Combination Products: The OCP processed Request for Designation (RFD) submissions, ensuring timely classification and Center assignment for new combination products.
- Timely, Effective, and Aligned Premarket Review: The OCP supported the efficient review of combination products by coordinating inter-Center consultations and providing guidance to sponsors, thereby expediting patient access to new treatments.
- Consistent and Appropriate Postmarket Regulation: The OCP provided clarification and support for postmarket matters, including working with FDA Centers on manufacturing compliance and safety reporting requirements.
- Policy and Procedural Activities: The OCP continued to develop and refine policies and procedures to enhance clarity, predictability, and consistency in the regulation of combination products, including publishing guidance documents and streamlining processes.
- External Outreach: The OCP engaged with stakeholders through presentations and collaborations to foster a better understanding of combination product regulation and identify areas for international regulatory convergence.
For detailed information on specific activities and performance metrics, please refer to the full report.
