U.S. Department of Health and Human Services / Congress / Food and Drug Administration office of Combination Products Contains Nonbinding Recommendations TABLE OF CONTENTS I. Introduction / Ombudsman Center for Devices and Radiological Health / Food and Drug Administration / FDA Center / office of Combination Products / FDA / Ombudsman Center for Biologics Evaluation / /
Final Dispute Resolution Guidance Document - Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product