FDAAA Leadership
Steven Niedelman
Steven Niedelman retired from FDA after 34 years as the Deputy Associate Commissioner for Regulatory Operations and COO of the Office of Regulatory Affairs, providing direct oversight over the agency's field offices and laboratories, Office of Criminal Investigations, and Office of Enforcement. Prior to that he served as the Director of the Office of Enforcement, where he assured consistent interpretation of regulatory, recall, and enforcement policies and procedures across all of FDA's five scientific specialty centers. Mr. Niedelman spent nearly 24 years at the Center for Devices and Radiological Health where he held several management positions in the Office of Compliance. He began his FDA career as a Consumer Safety Officer in the New York District Office. He currently is a senior consultant with the law firm of Crowell & Moring. He was previously Executive Vice President of Quintiles Consulting.