Mr. Krueger joined Biologics Consulting in April 2020, after more than 15 years with the U.S. Food and Drug Administration (FDA) in the Center for Devices and Radiological Health (CDRH). His experience includes over 6 years in pre-market submissions including PMAs, HDEs, 510(k)s, IDEs, 513(g)s, and de novo submissions and over 11 years reviewing and supervising the review of manufacturing information and compliance actions, including Quality Systems, PMA and HDE manufacturing information, recalls, allegations, injunctions, seizures, civil money penalties, and warning letters. His experience involves a variety of devices areas including cardiovascular, orthopedic, neurology, physical medicine, and dental devices. He has also worked on combination products with CDRH, CDER, and CBER as the lead reviewing centers.
Before joining Biologics Consulting, Mr. Krueger worked as an Assistant Director overseeing the Neurosurgical Team in the Office of Product Evaluation and Quality’s Office of Neurology and Physical Medicine Devices. As the Assistant Director, he was involved in all aspects of pre-market and post-market review of neurosurgical devices. Mr. Krueger joined the Office of Product Evaluation and Quality and the Office of Neurology and Physical Medicine Devices as part of 2018 reorganization of CDRH.
Prior to joining the Office of Product Evaluation and Quality, Mr. Krueger worked in the CDRH Office of Compliance where he started as a Biomedical Engineer and reviewer in the Vascular and Circulatory Support Branch. He went on to be the Branch Chief of the Orthopedic and Physical Medicine Devices Branch in the Division of Enforcement B and then following a reorganization, the Physical Medicine, Orthopedics, Neurology, and Dental Devices Branch in the Division of Manufacturing and Quality. As the branch chief, he was responsible for overseeing the review work of staff who reviewed regulatory actions such as injunctions, seizures, civil money penalties, and warning letters, as well as establishment inspection reports, recalls, allegations, promotion and advertising, and PMA and HDE manufacturing information for original and site change supplements. In 2017, Mr. Krueger completed a detail serving as the Acting Division Director for the Division of International Compliance Operations (DICO) where he managed branches responsible for foreign enforcement, imports, exports, and the Medical Device Single Audit Program (MDSAP) giving him experience and insight into each of these regulatory programs.
In his first position with the FDA and prior to working in the Office of Compliance, Mr. Krueger was a Mechanical Engineer and reviewer in the Office of Device Evaluation’s Division of Cardiovascular Devices, working in the Peripheral Vascular Devices Branch. As a Mechanical Engineer, he served as both a lead reviewer and a consulting reviewer for Mechanical Engineering testing on a variety of vascular devices including peripheral and coronary stents, IVC filters, endovascular stent grafts, endovascular catheters and delivery systems.
Mr. Krueger received his BS in Mechanical Engineering from Southern Methodist University, and MS in Bioengineering from the University of Pennsylvania.