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Interview

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ASTM Chairman of the Board Donald E. Marlowe is the director of the FDA’s Office of Science and Technology Center for Devices and Radiological Health, which is located in Rockville, Md.

Center for Devices and Radiological Health

CDRH, part of the U.S. FDA, helps ensure that medical devices are safe and effective as authorized by the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act and helps reduce unnecessary exposure to radiation from medical, occupational, and consumer products as authorized by the Radiation Control for Health and Safety Act of 1968.

Office of Science and Technology

OST, the laboratory research hub of CDRH, supports FDA’s regulatory decisions with laboratory research in the areas of standards, technical consultation, forensic analysis, and applied research. It leads the development and evaluation of standards used for regulatory assessments. OST supports other Center offices when specific expertise is required and identifies and analyzes failures of marketed devices. OST conducts research in the areas of life, physical, and engineering sciences as they relate to the health effects of radiation and medical device technologies, e.g., studying the effects of electrical fields around consumer products on cell development. OST’s research assists the regulatory programs of CDRH and FDA in anticipating the impact of technology on the use, safety, and effectiveness of regulated products.

The work of OST can be divided into two main areas: the generation of information and information processing. In the generation of information, roughly half the office’s
effort is spent on research aimed at current regulatory problems identified by other parts of CDRH and FDA. The information processing segment includes the direct scientific and technical support for other FDA offices through consultation on device pre-market applications and post-market surveillance.

Just a few of the many OST programs include:

• Failure Analysis of Electronics in Medical Devices—Applies readily available tools and methods to the laboratory evaluation of medical device performance.
• Software Engineering—Concentrates on four areas that OST considers to be the most critical steps in the process of generating safe software. These areas are: 1) Software Requirements, Analysis, and Definitions; 2) Software Design Methods; 3) Software Hazard Analysis; and 4) Software Verification, Validation, and Testing.
• X-Ray Instrument Calibration, Field Support, and Laboratory Accreditation— Provides traceability to national standards for all x-ray measurements related to the enforcement of FDA regulations.
• Medical Imaging Evaluation—Develops consensus evaluation methodology for diagnostic medical imaging systems such as mammography and other film-screen x-ray systems, computed tomography, nuclear medicine, diagnostic ultrasound, magnetic resonance imaging, and digital imaging including fluoroscopy and digital mammography.
• Foreign Body Reactions and Adverse Biological Effects of Chemicals—Medical device implants are known to cause inflammation, infection, and scar formation. In-vivo and in-vitro models are being used to define the effects of medical device materials on critical inflammatory functions and their clinical relevance.

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Copyright 2001, ASTM