||ASTM Chairman of the Board Donald E. Marlowe is the director of
the FDAs 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 FDAs 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. OSTs 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 offices
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 DevicesApplies readily
available tools and methods to the laboratory evaluation of medical
Software EngineeringConcentrates 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 EvaluationDevelops 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 ChemicalsMedical
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.
Copyright 2001, ASTM