David Kalins FDA

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David Kalins FDA

Dave began his career with the FDA in 1977 as an Investigator assigned to the Baltimore District Office performing medical device and drug inspections. After several years in the field, he transferred to FDA’s Rockville, MD, Center for Devices and Radiological Health headquarters working with laser, sunlamp and other medical products. In 1990 he advanced to a position in CDRH’s Office of Compliance where he served as a Case Management Specialist, working with field offices and directing regulatory actions and investigations. In this capacity he conducted many criminal investigations working with the U.S. Attorney’s office.

David was also a Branch Supervisor in the Center’s Division of Bioresearch Monitoring where his Branch was responsible for special investigations and monitoring the data quality of clinical research used to support the safety and efficacy of medical devices. His Branch also provided oversight of non-clinical trials and research.

From 1995 to the time of his retirement, David served in the Office of the Director, Office of Compliance, as the regulatory case and policy expert, providing oversight of OC staff on most regulatory actions and compliance policy for CDRH/OC. He also served as the office’s Field Liaison, coordinating CDRH communications with FDA’s field force. He also was responsible for managing the Center’s Accredited Person’s 3rd Party inspection program. In his last year, he completed multiple details as the Acting Deputy Director for Regulatory Affairs for the Office of Compliance, CDRH.

Dave retired from the FDA October, 2012 with 30 years of service. Since then, in addition to proving “oversight” of his 4 grandchildren, he has been active serving as a medical device regulatory and quality consultant to the industry.