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How to determine which FDA center will review a combination product
Summary
FDA panelists advised sponsors to submit a Request for Designation (RFD) to the Office of Combination Products; the office assigns a lead center (CBER, CDER, or CDRH) based on the product's primary mode of action and posts RFD process details on FDA.gov.
Ramani Sista, moderator and director for the Office of Review Management and Regulatory Review in OTP, said sponsors unsure which FDA center will review a biologic-device combination should submit a Request for Designation (RFD) to FDA's Office of Combination Products. "If you are unsure which FDA center will review your proposed product, you may submit a request for designation or RFD to FDA's office of combination products," Jessica Behmer, associate director for regulatory policy, said during the town hall.
Behmer described how the Office of Combination Products assigns review responsibility to a lead center — the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), or the Center for Devices and Radiological Health (CDRH) — based on the product's primary mode of action, and she directed sponsors to FDA's RFD web page for submission instructions. The panel urged sponsors to consult the RFD guidance early to avoid misrouting and delays in review.
