Apr 01, 2005
Donald E. Marlowe, agency standards coordinator for the U.S. Food and Drug Administration (FDA) in Rockville, Md., where he also resides, has been chosen to receive a 2005 ASTM International Award of Merit and the accompanying title of Fellow. For the award, ASTM Committee F04 on Medical and Surgical Materials and Devices cites Marlowe's dynamic and outstanding leadership in fostering the development and promulgation of surgical implant standards. The honor is the Society's highest recognition for individual contributions to standards activities.
An ASTM International member for more than 35 years, Marlowe currently serves as chair of E55 on Pharmaceutical Applications of Process Analytical Technology, a committee of more than 100 members focusing on PAT system management, implementation and practice, and terminology. Marlowe has also been active in Committees D11 on Rubber, E09 on Fatigue, E28 on Mechanical Testing, E56 on Nanotechnology, F30 on Emergency Medical Services, and the Committee on Technical Committee Operations. He is currently chairman of F04.95, the U.S. Technical Advisory Group for ISO TC 168 on Orthotics and Prosthetics. A member of the ASTM Board of Directors from 1994 to 2003, Marlowe was Chairman of the Board in 2001 and chairman of the Finance and Audit Committee in 1997 and 1998.
Marlowe began his career in 1963 as a mechanical engineer with the National Bureau of Standards (NBS) (now the National Institute of Standards and Technology, or NIST). He became a project leader in NBS' Composite Materials Program and later chief of the Dynamic Measurements Group. In 1977, he joined the FDA as a senior mechanical engineer with the Research and Testing Staff of the FDA Bureau of Medical Devices. Marlowe served as director of the Division of Mechanics and Materials Sciences from 1984 until 1995, and director of the Office of Science and Technology at the FDA Center for Devices and Radiological Health from 1995 until 2001. He has been the Agency Standards Administrator since October 2002.
Outside ASTM International, Marlowe serves as a member of the ISO Technical Committee on Biological Evaluation (TC 194), co-leader of the U.S. delegation to TC 194 and Convener of the Working Group on Sample Preparation and Reference Materials. He is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), the American Society of Mechanical Engineers, and a fellow of the American Institute for Medical and Biological Engineering.
Marlowe holds bachelor's degrees in physics and mechanical engineering and a master's degree in solid mechanics from the Catholic University of America in Washington, D.C. In addition, he has written more than 50 papers and presentations in the areas of material properties, product testing, analysis of medical devices, and consensus standards development.
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