Daniel G. Walter

Daniel Walter is currently the Chief of the Foreign Enforcement Branch in the Division of International Compliance Operations within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. The branch oversees the compliance efforts for medical device manufacturers outside the United States, and includes inspection review, recall classification, and administration of allegation of regulatory misconduct, as well as assisting the office, Center, and Agency for cross-cutting initiatives, for all device types. Daniel began his career at FDA as a compliance officer in, then was promoted to the branch chief of, the Vascular and Circulatory Support Branch in the Office of Compliance at CDRH. He is currently acting as the Branch Chief in the Gastroenterology Devices Branch of the Division of Reproductive, Gastro-Renal, and Urological Devices in ODE, working with epidemiologists and Medical Device Reporting analysts in OSB, to develop cross-cutting mechanisms to enhance patient outcomes through information sharing by developing “benefit-risk” based evaluation processes. Prior to working with FDA, Daniel Walter was a Validation Engineer, leading to becoming the Lead Quality Auditor and Director of Quality at DST Controls. Daniel’s experience includes facility, utility, equipment, and process validations for automated and non-automated systems, including for steam and compressed air distribution validations, cleaning validations, self-contained automated manufacturing lines for liquid and solid pharmaceutical manufacturers.