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U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health
OFFICE OF SCIENCE AND ENGINEERING LABORATORY DIVISIONS
Genomic and Genetic Devices
Host Response: Tissue-Materials Interactions and Tissue-Device Interactions
Biological Risk Assessment
Biotechnology and Biomolecular Studies
Materials Characterization and Polymer Degradation
Medical Imaging and Diagnostics
Fluid Dynamics and Ultrasonics
Radiation Bioeffects
Electrophysiology and Electrical Stimulation
Electrical, Electronics, and Software Engineering
Optical Physics Diagnostics and Therapeutics
Electromagnetics and Wireless Technologies
Radiological Health and Safety
Mechanics of Materials and Structures
APPENDIX A OSEL Publications
APPENDIX B OSEL Presentations
APPENDIX C OSEL Academic Affiliations
APPENDIX E OSEL-Sponsored Seminars
APPENDIX F OSEL Laboratory Tours
APPENDIX G - FDA FY 2004 Award Grants for Collaborative Science Projects
APPENDIX H - Abbreviations and Acronyms
The mission of the Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) is to promote and protect the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.
The Office of Science and Engineering Laboratories (OSEL), formerly the Office of Science and Technology (OST), is one of seven Offices within the Center for Devices and Radiological Health (CDRH). The seven CDRH Offices are comprised of six program offices (of which OSEL is one) and one administrative and technological support office. OSEL serves as the laboratory science nucleus for the Center. Specifically, OST/OSEL supports the scientific basis for the Agencys regulatory decision- making by developing independent laboratory information for regulatory and other public health activities of CDRH. In addition to providing consultation to the Centers regulatory experts, OST/OSEL researchers are involved in mission-oriented science activities including test methods development, risk assessments, forensic investigations, product evaluations, and technology forecasting.
From a science standpoint, OST/OSEL conducts laboratory and field research in the areas of physical, life, and engineering sciences as related to the human health effects of medical devices. CDRH relies upon this work to support its efforts ensuring public safety in areas as varied as accredited mammography facilities, breast implants, or drug eluting stents.
Since mid-2003, the Office has undergone at least three major changes which have helped shape the new organization, the Office of Science and Engineering Laboratories (OSEL). The first was the move of the newly reorganized Division of Biology to the newly constructed FDA Life Science Laboratories in White Oak, Maryland. This move was the beginning of a planned consolidation of FDA facilities. The remaining OSEL divisions are expected to move to the White Oak facilities in 2006. The second change concerns the science prioritization process. In the beginning of 2004, the Office conducted a review of all 14 programs in an ongoing process. The third and final major change is the reorganization itself. OST was formally reorganized in early 2004 to improve the overall operating efficiency of the Office and to better integrate it into the mission and functions of CDRH. This reorganization is expected to clarify the ongoing research within the Office for both FDA and outside scientists. The reorganization has created a new structure in which six new divisions have replaced the four former divisions in OST and has removed all designated branches. The new office is named the Office of Science and Engineering Laboratories (OSEL).
This reorganization has taken place at a crucial time. Over the past few years, with MDUFMA (Medical Device User Fee and Modernization Act of 2002) legislation and accompanying resources, the Office has had an opportunity to broaden and improve its scientific program. This gives the management an excellent incentive to increase the collaboration with other components of CDRH. Finally, with the recent move of the life sciences staff to White Oak and the impending construction of the engineering and physics building, the prospects for OSEL are promising.
OSEL long-term goals focus on the following:
The OSEL Annual Report provides current information about the Offices organization and intramural science activities; provides a summary of the Offices direct laboratory support for pre-market review and compliance cases; and provides a bibliography of scientific publications, presentations, and research seminars for the fiscal year. OSEL management welcomes comments on the programs described in this report. We hope you find this report useful and informative, and your comments are welcome.
For additional information, please contact us at 301.827.4777.
Larry G. Kessler, Sc.D. |
OFFICE OF SCIENCE AND ENGINEERING LABORATORY DIVISIONS |
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DB participates in the Center's mission by conducting research,
participating in device review activities, developing consensus standards
both domestic and international, developing regulatory guidance, testing
forensic and regulatory samples, and providing educational programs in the
area of biological sciences. Specifically, DB conducts research to support
the Centers mission to assure the safety and effectiveness and promote
the improvement of medical devices in the areas of biological risk assessment,
biosensors/nanotechnology, genomic and genetic technologies, infection control
and sterility, tissue-device interactions, toxicity/biocompatibility, and
radiation bioeffects. Through laboratory studies, researchers evaluate
the potential adverse effects of medical devices on host biological systems
and, in collaboration with engineering divisions, identify the source and
impact of product degradation on organ systems both under acute
and chronic conditions. The Division staff develops measurements methods
and analytical procedures to characterize and evaluate devices and products,
studies molecular and cellular mechanisms and bioeffects of biomaterials,
and supports the Centers enforcement and product testing activities.
The DB staff members are primarily biologists, chemists, and biomaterials scientists. |
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DCMS participates in the Center's mission by conducting research,
participating in device review activities, developing consensus standards
both domestic and international, developing regulatory guidance, testing
forensic and regulatory samples, and providing educational programs in the
area of chemistry and materials sciences. Specifically, the DCMS focus is
on the developing experimental data, test methods and protocols for regulatory
and scientific activities involving multicomponent mass transfer, reaction
kinetics, absorption and swelling of network polymers, polymer processing,
modeling of physiological processes, and materials degradation. Research
conducted in the division includes polymer synthesis; synthesis of polymeric
nanocomposite materials; sensors; thermodynamics; thermal transitions and
phase stability; hydrogel and biopolymer synthesis and characterization;
polymer formulation; separations; spectroscopy; small-angle x-ray and neutron
scattering; and shelf-life and service life prediction. DCMS tests the performance
of chemical processes of importance to medical devices, such as mass transfer
through membranes used in dialysis and blood oxygenation, and manufacturing
processes used to fabricate materials.
The technical disciplines of the DCMS staff include physical chemistry, chemical physics, polymer science, pharmacology, materials science, and biomedical and chemical engineering. |
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DESE participates in the Center's mission by conducting research,
participating in device review activities, developing consensus standards
both domestic and international, developing regulatory guidance, testing
forensic and regulatory samples, and providing educational programs in the
area of electrical engineering and software. Specifically, the DESE works
in the application of electronics, software engineering, and systems engineering
body of knowledge to the regulation of medical devices and electronic products
that emit radiation. The division addresses the cutting edge of medical
devices through all phases of the product life cycle and all aspects of
the product manufacturers business, from research and development
through procurement, production, and ongoing customer support. DCMS hosts
the following resources and capabilities: analog and digital circuit design,
data acquisition and display, embedded microprocessor and PC-based systems,
software-based virtual instruments, quality management and risk management
as applicable to electronics and software, testing for hazards arising from
the use of electrical and electronic technology in medical products, and
electronic design including components, circuits, and analytical techniques
for controlling high voltages and/or currents.
DESE staff members are primarily electronics engineers, physicists, biomedical engineers, and general engineers. |
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DIAM participates in the Center's mission by conducting research,
participating in device review activities, developing consensus standards
both domestic and international, developing regulatory guidance, testing
forensic and regulatory samples, and providing educational programs in the
area of medical imaging and applied mathematics. Specifically, DIAM provides
scientific expertise and carries out a program of applied research in support
of CDRH regulation of radiation-emitting products, medical imaging systems,
and other devices utilizing computer-assisted diagnostic technologies. Medical
imaging research encompasses ionizing and non-ionizing radiation from data
capture through image display and observer performance. The computer-assisted
diagnostics work of DIAM is focused on the appropriate mathematical evaluation
methodologies for sophisticated computational algorithms used to aid medical
practitioners interpret diagnostic device results. The Division is charged
with developing and disseminating performance assessment methodology appropriate
to these modalities. DIAM operates a calibration laboratory for ionizing
radiation detection instruments and participates in a full range of programs
in support of the Public Law 90-602 mission of the Center.
DIAM staff members are primarily physicists, mathematicians, and physical science technicians. |
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DP participates in the Center's mission by conducting research,
participating in device review activities, developing consensus standards
both domestic and international, developing regulatory guidance, testing
forensic and regulatory samples, and providing educational programs in the
area of physics. Specifically, DP conducts research and engineering studies
to support the Centers mission to assure the safety and effectiveness
of medical devices and electronic products, and to promote their improvement.
Scientific and technical specialties in the division include optical physics
and metrology, sensors, fiber optics, electromagnetics, electromagnetic
compatibility and electromagnetic interference, electrophysics and electrical
stimulation technologies, electrophysiology, radiofrequency/microwave metrology,
and minimally invasive optical and electromagnetic technologies. The Division
develops measurement methods, instrument calibration capabilities and analytical
procedures to characterize and evaluate devices and products, and supports
the Centers enforcement and product testing activities. DP evaluates
interactions of electromagnetic and optical energy with matter, analyzes
implications for the safety and effectiveness of devices and products, and
develops and evaluates procedures for minimizing or optimizing human exposure
from such devices.
The technical disciplines of DP staff include physics, mathematics, biophysics, biomedical engineering, electronics, and general engineering. |
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DSFM participates in the Center's mission by conducting research,
participating in device review activities, developing consensus standards
both domestic and international, developing regulatory guidance, testing
forensic and regulatory samples, and providing educational programs in the
area of solid and fluid mechanics. Specifically, the core responsibilities
of this division involve issues for which mechanical interactions or transport
are of primary concern, such as those involving motion; structural support,
stabilization, or vibrations; device and material mechanical integrity;
materials durability; and biologically relevant parameters of device and
materials. The division has expertise in the areas of fluid dynamics, solid
mechanics and materials, acoustics and ultrasonics. DSFM develops measurement
methods, instrument calibration capabilities, and analytical procedures
to characterize and evaluate devices, device materials, and products, and
supports the Center's enforcement and product testing activities. The division
staff also evaluate interactions of ultrasound energy with matter and the
implications of these interactions on the safety and effectiveness of devices
and products.
Technical disciplines of the DSFM staff include mechanical engineering, materials science, biomedical engineering, general engineering, and physics. |
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The SMS is responsible for developing, managing, and supporting
standards used for regulatory assessments. SMS manages the participation
of CDRH and other FDA staff in standards development. This involves working
closely with the Standards Developing Organizations (SDOs), advertising
standards liaison representative positions, facilitating a Center recommendation
to serve on a particular standards activity, maintaining a standards database
that provides access to established standards to all CDRH staff and field
inspectors.
SMS increases the recognition of voluntary consensus standards for medical devices and radiation-emitting electronic products. The Standards Program was created as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. Although CDRH had been involved in the development of medical device standards for decades, FDAMA formalized the process. As part of this responsibility, the staff publishes lists of recognized standards annually and consistently increases the list of available standards. SMS supports participation in medical device standards committees. The staff accomplishes these tasks with the help of Standards Task Groups (STGs). Additionally, the SMS assists in setting teams in the development of guidance documents that help CDRH stakeholders in improving the quality of submissions as well as in faster approval of device applications. |
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MSS provides leadership and support to the Office of the
Director, Division Directors, and laboratory professionals on all administrative,
general management, and knowledge management issues. MSS is responsible
for planning, developing, and implementing Center and OSEL programmatic
matters concerning financial management, personnel, procurement, contracts,
inter-agency agreements, employee training, and facilities.
MSS is tasked with the managing and administering OSEL resources designed to support ongoing programs. The staff ensures the proper distribution of operating and payroll dollars, facility plans, procurement and property, travel requests and ADP needs. MSS advises the Office of the Director on potential issues that may affect resources, staffing, and management issues to comply with policies and avoid potential conflicts. In addition, MSS directs and conducts special assignments or projects for the Center as well as the Office Director. MSS is also tasked with Knowledge Management Support (KMS) for the office. The KMS team provides technical support for the acquisition, retrieval, and analyses of data supporting the offices mission including developing specialized databases and related applications where needed. Additionally, the staff performs specialized activities associated with the development, design, installation, and administration of data processing systems, particularly those that are integral to laboratory functioning. The KMS team collaborates with the Office of Systems and Management (OSM) and the Office of IT Shared Services (OITSS) in developing major initiatives involving OSEL, CDRH, and FDA data and systems. The KMS staff also coordinates OSEL activities with these offices to assure compliance with Center and FDA policies regarding data structure and format and with FDA initiatives to assure data consistency and compatibility. |
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OSEL PROGRAM AREAS |
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Genomic and Genetic Devices
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Scope The revolution in human genetics and the sequencing of the human genome have created new opportunities for advances in public health and new challenges for FDA. Opportunities include the integration of genetic information into routine medical practice, e.g., for use in optimizing individual therapies. The new technologies can also be used to address the issues of safety and effectiveness of products undergoing pre-market review and to address post-marketing issues such as adverse responses. The challenges arise for CDRH as the Center responsible for approving new genetic and genomic diagnostic devices. A major challenge is establishing approaches for review and approval of novel diagnostic devices that provide hundreds or thousands of data sets generated simultaneously on microarrays. A microarray is a small piece of glass, plastic, silicon, or other material on which thousands of samples of DNA (e.g., oligonucleotide probes) or other receptor material (e.g., antibodies, tissues) have been attached in tiny pinpoint samples in a two- or three-dimensional format.) Microarrays are used to screen a biological sample for the presence of thousands of genetic sequences, proteins, or other targets at once, for example, to study gene expression. The need for genetic diagnostic tests that rapidly identify agents of bioterrorism and genomic human responses to these agents will add a level of urgency to the pre-market review responsibility faced by the center. Background Projects under this program are designed to provide hands-on knowledge and experience using the new technologies. A major effort is being devoted to the evaluation of microarray technology and device performance, in order to contribute substantively to standards development for genetic and genomic diagnostic devices. Although the technologies are new in some respects, they can still be validated against known surrogates. Projects are chosen that are informative for a particular device issue, such as factors related to microarray performance, a new approach to safety or effectiveness efficacy evaluation, or data that contribute to understanding and preventing adverse events. Projects are also designed to provide a basis for keeping up with the technologies as they evolve. There are two basically different types of devices representing the new technology coming to CDRH for review: genetic and genomic testing devices. A genetic test determines the presence or absence of a particular, targeted DNA sequence already known (or suspected) to be related to a health outcome. Examples are mutations in the cystic fibrosis gene (human genetic disease), in a drug metabolizing gene (efficacy of a given class of drug), in the p53 gene of a tumor (prognosis and therapeutic stratification), or in genes related to susceptibility to cardiovascular disease or cancer. One expectation is that pharmaceutical companies will submit applications for approval of combination products, e.g., a genetic diagnostic test along with a drug, in order to stratify a clinical trial population, or to include or exclude a certain segment of the population. Another use of genetic tests is to rapidly identify pathogens that may be used in terrorist attacks. Genetic testing is an established technology. It involves a query for a mutant sequence, usually within one gene. Microarrays can be used for parallel queries of many potential mutations or sequence identities. The genomic type of diagnostic test involves gene expression, usually measured by mRNA or a surrogate, often in comparison to a reference set of expressed genes. Genomic technology involves analysis of many hundreds or thousands of genes that are up-regulated or down-regulated either constitutively or in response to a stimulus. The result is a pattern of gene expression that is designed to be diagnostic or characteristic of a condition. Examples would be patterns related to toxic responses, characteristic of a disease subset or representative of a human response to a pathogen. Diagnostic devices can also be used to analyze expression profiles of proteins, the end-products of gene expression (i.e., Proteomics). Microarrays can be used to generate, and bioinformatics used to analyze, the complex patterns generated by genomic/proteomic and genetic devices. Whole genome analysis is relatively new and experimental, and methods and analytical approaches are still being developed. Program Description Because genetic and genomic devices are based on different technologies, projects are underway in each area. Issues are described below.
These projects provide a base for genomic and genetic device performance evaluation, and for continuously updating our capability in new technologies as they evolve. The knowledge and experience gained including methods design and development, as well as device performance evaluation, will enable OSEL scientists to do the following: 1) make informed regulatory decisions by critically evaluating data obtained with diagnostic devices based on genomic and genetic technology, and 2) contribute to writing standards and guidance documents. The projects will also demonstrate some of the ways in which new genetic and genomic approaches can enhance public health. Mastery of genomic and genetic technologies involved in these projects will prepare us for possible future projects involving the rapid detection of microorganisms and human host responses associated with biodefense. The projects in this program support the CDRH Strategic Plan, especially the Total Product Life Cycle and Magnet for Excellence. Additionally, collaborations within FDA, with other government organizations, academia, and industry have provided ample opportunity for significant leveraging of resources and expertise. Relevance to FDA and CDRH Mission, Program, and the Public Health impact Scientists in this program area are developing and performing laboratory projects that give them hands-on experience with emerging microarray-based and related molecular technologies. The knowledge and experience gained, including methods design and development, as well as device performance evaluation, will enable OSEL scientists to 1) participate effectively in the CDRH regulatory review of pre-market device applications, 2) make informed regulatory decisions by critically evaluating data obtained with diagnostic devices based on genomic and genetic technology, 3) contribute to writing standards and guidance documents. The projects will also demonstrate some of the ways in which new genetic and genomic approaches can enhance public health. Mastery of genomic and genetic technologies involved in these endeavors will prepare us for possible future projects involving the rapid detection of microorganisms and human host responses associated with biodefense. In addition, collaborations within FDA, with other government organizations, and with academia and industry have provided ample opportunity for significant leveraging of resources and expertise. Five-Year Objectives
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Host Response: Tissue-Materials Interactions and Tissue-Device InteractionsScope This is an interconnected program of laboratory research, risk assessment, and standards development activities designed to provide a scientific basis for regulatory decision making in CDRH. The data on potential adverse effects of medical device materials and chemicals gathered from pre-clinical experimental approaches in this program are used to reduce uncertainties in assessing risks to patients exposed to physical and chemical insults, and protect their health. Background In 1983, the Bureau of Radiological Health and the Bureau of Medical Devices were merged into the Center for Devices and Radiological Health. This merger presented the new Center with a disparity between the research programs devoted to radiation issues and those devoted to medical device issues. Additionally, a discontinuity existed between classical chemical toxicology and the potential adverse health effects posed by exposure to medical devices. To address this need, OSEL expanded the existing radiation research program to include medical device toxicology. More recently, the program has evolved to address the development of toxicological and microbiological approaches to risk assessment and investigation of biological issues relating to infection control and tissue-engineered medical products (TEMPs). Program Description: The "Host Responses: Tissue-Materials Interactions, Tissue-Device Interactions" research program encompasses two major areas: 1) Biological Effects of Chemicals and Medical Device Materials, and 2) Infection Control. 1) Biological Effects of Chemicals and Medical Device Materials Immunological/Inflammatory/Proliferative effects. OSEL scientists are conducting research to examine the immunological, inflammatory, and proliferative effects of materials and chemicals released from materials, including examination of the stimulation of chronic inflammation by particles using both in vitro and in vivo models, and the induction of allergic responses by material constituents, such as natural rubber latex proteins and metals. In addition, scientists are conducting research on the ability of compounds incorporated into a device (e.g., drug-eluting coronary stents) that are intentionally released in order to mitigate inflammatory or cell proliferative responses induced by the device. Toxicity of compounds released from medical device materials. OSEL is involved in investigating the adverse effects of compounds (e.g., metals, DEHP, ethylene oxide, bisphenol A, endocrine disruptors) released from medical device materials using small and large animal models, developing toxicity tests specific for medical device materials (e.g., polymers that cure in situ), and developing biomarkers to detect early cell and tissue damage caused by compounds released from devices. Biological effects of nanotechnology products and tissue engineered medical products (TEMPs). The development of TEMPs and nanoparticles in health care delivery is at the cutting edge of medical device technology. OSEL is developing test methods to examine the potential tissue interactions of these materials and medical devices, such as TEMPs scaffold materials and nanoparticles, in patients receiving the device and on the cells and tissues that are components of the device. 2) Infection Control Relevance to FDA and Public Health Impact The experimental studies in this laboratory research program generate independent data for assessing toxicological risks and for developing standards and guidance documents. OSEL remains at the forefront in medical device toxicology and for developing methods for risk assessment. Specifically, OSEL serves as an independent source of data on medical device toxicology and risk assessment for risk managers in CDRH Offices. These data and risk assessments provide a scientific basis for developing important pre-clinical and post-market activities, such as developing ASTM standards for testing biological responses to particles both in vivo (F1904-98) and in vitro (F1903-98), ISO standards (e.g., ISO 10993-17) for establishing tolerable intake values, Federal rule-making (e.g., for natural rubber latex protein content in gloves and condoms), and for risk management decision-making in the Center (e.g., FDA Public Health Notification for DEHP in medical plastics). Five-Year Objectives Long-term objectives include 1) develop and establish test methods and models for evaluation of potential adverse effects of medical device materials, and medical devices, including elucidation of new, clinically relevant, and sensitive biomarkers to predict adverse effects in the preclinical stages of product development, and 2) characterize the potential adverse effects using pre-clinical laboratory models and utilizing the data to predict the likelihood of adverse effects in humans. |
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Biological Risk AssessmentScope Risk assessment is the process of determining the extent of human health hazard relative to exposure conditions. Staff in the OSEL biological risk assessment program conduct research to address CDRHs regulatory need for improved methods of detecting and quantifying risks associated with 1) chemical compounds released from medical device materials, 2) microorganisms associated with medical devices, and 3) exposure to radiation. Research in the program is designed to reduce uncertainties in the risk assessment process and to support risk management decision-making in the Center. The program is closely linked with the Tissue-Material Interaction Program and includes staff with expertise in toxicological, microbial, and radiation risk assessment. Background OSEL staff has long been responsible for conducting risk assessments of compounds released from medical device materials. These risk assessments have been directly used to support regulatory decision making in the Center (e.g., microbial risk assessment to support Sterility Assurance Levels, DEHP Safety Assessment to support the issuance of a Public Health Notification and draft labeling guidance). More recently, staff have been involved with the development of the ISO 10993-17 standard, Method for the Establishment of Allowable Limits for Residues Using Health Based Risk Assessment. Toxicity studies used for the risk assessment of compounds released from medical devices are almost always conducted using healthy animals; however, patients exposed to these compounds may be critically ill or injured. A number of studies have demonstrated that the potency of some compounds is potentiated by conditions such as renal failure, liver failure, and sepsis. Therefore, a tolerable intake (TI) value derived for a compound in a study that uses healthy animals may not be adequately protective for a critically injured patient. In the ISO/DIS 10993-17 standard, the approach for deriving a TI involves application of a default Uncertainty Factor (UF) of 10 to account for inter-individual variability in the human population, in the absence of more specific data to identify sensitive subpopulations. However, it is not clear whether this default UF is adequate to protect critically ill or injured patients from the toxic effects of compounds released from medical devices. To address this broad issue, animal models of compromised health will be developed in our laboratory and used to examine whether the potency of compounds is increased in experimental animals with compromised health compared to healthy animals. These models will also be used to assess the impact of ultrasound contrast agents on the vascular endothelium and to develop new devices that can be used to assess tissue damage and functional changes in diabetic patients. Program Description FDA's Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. This broad mandate requires chemical, microbial, and radiation risk assessments to be performed to support regulatory decision making in these areas. Chemical risk assessment activities in CDRH focus on three areas: 1) the development and validation of new risk assessment methodologies, 2) bench-top research to provide information for the hazard identification and dose-response assessment stages of the risk assessment process, and 3) the application of risk assessment approaches to assist with regulatory decision making. Risk assessments have been used by CDRH to assist in reaching decisions on various issues that have received considerable attention in the media, including the safety of phthalate esters released from PVC devices, dioxin released from tampons, and 2,4-toluenediamine released from polyurethane-foam covered breast implants. The research component of the program is key in addressing uncertainties regarding the response of sensitive subpopulations to the effects of chemical compounds. Radiation risk assessment activities in CDRH focus on three areas: 1) assessing the risk of skin cancer, particularly malignant melanoma, from exposure to tanning lamps, 2) evaluating published results that state that there are possible health risks from exposure to radiofrequency radiation from cellular telephones, and 3) assessing any potential increases in risk from unnecessary ionizing or non-ionizing radiation from regulated medical devices and radiological products. Relevance to FDAs and CDRHs Mission, Program, and Public Health Impact Efficient, science-based risk management is a component of the FDA Commissioners five-part strategic action plan to protect and advance the health of Americans (http://www.fda.gov/oc/mcclellan/strategic.html). Risk assessment is the first step in the risk management process. The OSEL program in risk assessment involves laboratory-based efforts to address risk assessment uncertainties, development and validation of new risk assessment methodologies, and use of risk assessment to support regulatory decision-making. A key laboratory-based effort is directed towards examining whether critically ill or injured patients represent a sensitive subpopulation and can be more susceptible to adverse effects of chemicals. Research is also being conducted to address data gaps identified in risk assessments performed by the research staff (e.g., studies on the pulmonary effects of DEHP). Risk assessment methods are being developed as part of the process to create consensus standards for the biological evaluation of medical devices under the auspices of ISO. Five-Year Program Objectives
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Biotechnology and Biomolecular StudiesScope The laboratory studies of this program aim to ensure that there are consistent testing requirements and that the Center is aware of and understands cutting-edge biological technologies in developing new devices or device materials. Program Description Studies are proposed to address safety concerns about current and impending submissions of combination products, including the importance of possible immunotoxic reactions to incorporated biomaterials. The goal of these studies is to develop critical issues in the emerging field of combination product (i.e., biological matrices used in wound healing); issues in cardiovascular surgery; and issues addressing cell encapsulation. These studies will also address the potential of combination products to cause chronic inflammation. Laboratory investigations will address intravascular catheters which are coated or impregnated with antimicrobial or antiseptic agents. It is important to assess microbial contamination of catheters and other medical devices and to compare and evaluate the efficacy of antimicrobial treatments. These studies use biosensors which are tools for effective real-time biological analysis. Bioluminescence is explored as the technology for such analyses. Other studies explore the detailed mechanism of action of taxol or sirolimus in drug elutes stents. Mechanisms of action of platelets and and delayed endothelial healing leading to thrombosis will be investigated. Laboratory in vivo and in vitro exploration of neointimal hyperplasia leading to in-stent re-stenosis, as well as clarifying the factors that contribute to fatalities, are planned in these studies. Techniques using differential display will be developed for these analyses. Relevance to FDAs and CDRHs Mission, Program, and Public Health Impact Using new technology in developing medical devices for pre-market approval is anticipated as the trend of products generated by creative research and biotechnological progress. Much of the laboratory work at CDRH evaluates production of leachables released from devices. Questions about whether a finished device, device material, or extract of the device produce adverse biological effects can be addressed using new technology. Output from this work would appear in guidancesguidance documents, in review consults, and via scientific exchange. Reviewers can use these resources for rapid access to cutting-edge information. Five-Year Program Objectives
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Materials Characterization and Polymer DegradationScope In the pre-market phase, the synthesis, processing, and fabrication of materials are evaluated. These processes affect the molecular structure, phase, and ultimately the physical, chemical, mechanical properties, and biocompatibility of medical devices. Studies include residue and contamination analysis, purity, chemical structure and formulations, thermal stability, phase stability and transformation, transport and thermodynamic properties, viscoelastic, wet surface and adhesive properties. Computational methods are also used to predict physical and chemical properties when appropriate. Background The performance of a medical device in its intended function is ultimately related to the performance of the materials used under the particular service conditions to which the device is subjected. Thus, investigating the failure mechanism of medically relevant materials under a variety of service conditions becomes critical to CDRH's mission of assuring that medical devices are safe and effective. In order to achieve this goal, this program focuses on developing predictive, laboratory-based methods for determining the long-term stability of materials in contact with a variety of service environments. Included in this determination is identifying critical parameters, either in the device fabrication history, storage, or in the service environment, which can lead to failure through material related causes. These service environments vary by site of implantation, application conditions (oxygen rich atmospheres for example), or storage conditions of devices and components that could affect shelf life. Program Description The program is designed to contribute to evaluating medical device materials safety and effectiveness in the total product life cycle. The program laboratories are capable of testing the performance of chemical processes of importance to medical devices, such as mass transfer through membranes used in dialysis and manufacturing processes used to fabricate materials. The laboratories also contribute to testing, developing and assessing consistent and suitable characterization methods for the chemical, physical, and biological properties and characteristics of materials and devices. This program provides the Center with independent data as well as intramural knowledge and experience concerning the use of preclinical/post-market studies for the evaluation of medical device materials safety and performance. Additionally, the program evaluates the degradation of materials in storage or use in vivo or ex vivo, and identifies potential materials related failure modes. It contributes to the development of regulatory guidance and test methods to ensure the safety and effectiveness of medical devices and their material components. The materials degradation program evaluates the chemical, thermal, and environmental degradation of materials and the affect of degradation on medical device performance and safety. This effort includes many post-market evaluations of device failures and forensic investigations. Post-market forensic investigations of materials failures are very useful in advancing knowledge to ensure future problems are avoided. Factors such as the release of toxic degradation products, and diminished chemical or physical properties are evaluated. In addition to identifying the degree and mechanism of materials degradation, several models of materials degradation both in vivo and in vitro have been developed to predict the effect of the human body on materials in terms of degradation routes and ultimate outcome of degradation products. Some on-going and recent activities include unidentified particles in PVC blood bags, defective IV set fabrication, Intergel Adhesion Barrier and counterfeit polypropylene hernia repair mesh. The programs experimental pathology laboratory is equipped to evaluate the explant pathology of medical devices utilizing gross pathology, histopathology, immunohistochemical staining and molecular pathology studies. Additionally, physical and morphological materials characterization studies can be conducted focusing on x-ray, infrared and dynamic mechanical techniques to determine structure, chemical and morphologic changes resulting from the exposure of materials to the implant environment. The research program has provided independent data identifying heart valve failure modes associated with emerging polymeric and tissue-derived materials as well as the identification of a mechanism for the loss of cuspal cells in viable allograft heart valves following implantation. The knowledge and experience gained through these investigations have supported the regulatory decisions and recommendations made concerning four generations of replacement valves. The research in this program area is directed toward the development and establishment of in vitro and in vivo studies and models suitable for the evaluation of materials-tissue interactions, failure modes and effects analysis, and the assessment of medical device-related pathology. Peer-reviewed publications in the medical, materials science, and engineering literature serve as the scientific basis for regulatory guidance recommendations and standards development. Five-Year Program Objectives
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Medical Imaging and DiagnosticsScope A wide variety of new digital imaging and display devices are under development by academia and industry, with a broad range of performance characteristics. The Center thus requires new/improved guidance for the evaluation of such devices. To this end, OSEL scientists are developing evaluation methodologies for diagnostic medical imaging systems such as mammography and fluoroscopy, computed tomography, nuclear medicine, diagnostic ultrasound, and magnetic resonance imaging, as well as novel soft-copy display devices for viewing medical images. This program is located within the Division of Imaging and Applied Mathematics (DIAM). Background The Medical Imaging Program at CDRH was initiated in the early 1970s by its predecessor, the Bureau of Radiological Health (BRH). The goal was to go beyond the traditional BRH laboratory approach of simply measuring the level of radiation emitted by an electronic or diagnostic modality to measurement of the level of imaging performance as well. Laboratory measurement methods were developed for assessing the performance of contemporary and new technologies in the field of radiography, mammography, computed tomography, diagnostic ultrasound, radioisotope imaging, magnetic resonance imaging, and innovations in digital detectors and displays. The program led to contributions to consensus measurement methodology and international standards that are used here today in the approval process for new technologies, in particular, digital radiography and mammography, and diagnostic ultrasound. In-house research and collaboration with academic investigators have also led to laboratory and clinical systems that optimize the ratio of imaging performance to radiation exposure in mammography. Program Description DIAM scientists are developing appropriate methods for evaluating medical imaging system performance and dose. Investigations take the form of theoretical analysis, numerical simulation of the entire imaging chain, and experimental validation. In some instances improved/optimized system designs are validated through actual system construction and clinical evaluation. Measurement and analysis procedures are also being developed to evaluate the performance of new soft-copy display devices that can have dramatically different light-emitting structures and associated performance characteristics, whose impact on the image interpretation process is currently unknown. OSEL scientists provide reliable, quantitative laboratory measurements of imaging system characteristics to the imaging research community. These scientists are also elucidating the fundamental mechanisms underlying the interaction between the image-forming radiation and the anatomy being imaged. Relevance to FDA and CDRH Mission Program, and the Public Health Impact The expertise developed through this program is being applied to the review of PMAs for ultrasound bone sonometers and new digital radiographic imaging systems, the development of amendments to the diagnostic x-ray performance standard, the development of an advisory pertaining to pediatric CT exposures, and the joint planning of a consensus development conference on CT with NIH. The x-ray spectral measurements program provides a source of otherwise unavailable data to the entire mammography research community. Finally, investigating computer-assisted diagnosis devices provide the Center with the scientific basis to effectively regulate this fast growing field. Five-Year Objectives Future efforts in the Medical Imaging and Diagnostics program will focus on contemporary and emerging issues of regulatory interest. In the field of digital imaging, these issues include characterizing imaging performance without the underlying assumptions present for analog imaging systems, validating and refining consensus measures, optimizing overall system performance, and assessing tissue parameters from the digital data. Special emphasis with respect to imaging performance and patient exposure will be put on emerging techniques for volume imaging of the human anatomy including cone beam computed tomography using flat panel detector arrays. In the field of ultrasound, topics of interest include tissue characterization, bone densitometry, contrast agents, ultrasonic imaging system performance characterization, temperature mapping, elastography, and the use of ultrasonic measurements in pattern recognition systems. While DIAM continues to work in the area of ultrasound, the largest activity for this year involves high-intensity focused ultrasound, and is described in the program description for Fluid Dynamics and Ultrasonics. The Medical Imaging and Diagnostics program has made fundamental contributions to the field of statistical analysis of diagnostic imaging and systems for computer-aided diagnosis. We would like to exploit this work and validate its range of utility through extensive computer simulations. In the process, we would be seeking the most efficient or statistically powerful approaches to the evaluation of medical imaging and computer-assist decision modalities. An ultimate goal is the development of a multiple-reader (e.g., multiple radiologists, multiple pathologists) multiple-case (MRMC) version of our current software for ROC analysis in the absence of ground truth (i.e., without a gold standard). Development of such a system would address one of the most difficult yet most common assessment problems in the field of diagnostic medicine. Many statistical problems in the new field of bioinformatics remain unsolved. We would like to extend our contemporary successful research into new realms of bioinformatics that are opening up due to the accumulation of data from multiple testing and patient demographics. This will require continual upgrading of our computational facilities. |
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Radiation BioeffectsScope Numerous medical devices and consumer products regulated by CDRH emit radiation: ionizing (x-rays) or non-ionizing (ultraviolet radiation [UV], radio frequency, or acoustic radiation). In order for the public to enjoy the benefits of these products and technologies, it is necessary to establish safe limits for the exposures to these emissions (whether intentional or incidental) or provide scientific basis for reducing the exposures. The goal of the radiation bioeffects program is to develop scientifically based criteria for evaluating radiation-emitting medical devices and consumer products and for developing relevant CDRH/FDA guidelines and standards. Background Currently over 100 million Americans use wireless phones. Data relating to the safety of radiation from wireless phones are inadequate, however they suggest that exposures to radio frequency radiation at levels relevant to wireless phone use may cause biological effects. In this area, the OSEL bioeffects project serves as the coordinator of independent research conducted in several laboratories. These laboratories have been selected by CDRH, and OSEL is extensively involved in these investigations. The new findings together with other published data are being evaluated by OSEL for inclusion in appropriate FDA guidelines and standards. Program Description OSEL currently has a number of active programs to investigate (1) the safety of cell phones, (2) the biological effects of radiation emitted by radiation therapy devices for treating cancer or dermatological conditions, and (3) radiation emitted by or transmitted through consumer products such as tanning equipment or cosmetics (in collaboration with CFSAN, NCTR, and NCI). OSEL evaluates the bioeffects of acoustic (ultrasound) radiation to ensure safety of the diagnostic and therapeutic use of this modality. The bioeffects program also collaborates with other agencies, such as the National Toxicology Program, to initiate and coordinate broader programs such as a national study of the possible carcinogenicity of radio frequency radiation (nominated for study by members of the OSEL bioeffects program). In past years, the radiation bioeffects program has been involved in extensive collaborative research efforts with other national agencies in the areas of electromagnetic fields involved in the transmission and use of commercial electric power. In the future, the bioeffects program expects to become increasingly involved in the support of homeland defense and counter-terrorism that may involve radiological incidents. Currently the program is developing collaboration with the Department of Defense to study methods for identifying and testing new drugs to protect people from the effects of radiation such as might be released in a terrorist act. In another counter-terrorism area, our involvement will be needed for evaluating the radiation-emitting equipment proposed for security control at the entrances to sensitive areas (e.g., metal detectors at airport terminals). Five-Year Objectives The radiation bioeffects program is currently undergoing a shift in emphasis away from electromagnetic fields research, which was successfully completed with external funding from the National Electromagnetic Fields research program funded by Congress and administered by NIEHS. The currently strong program of UV research will continue to pursue new problems relating to UV radiation/tissue interactions and tanning equipment and is partnering with CFSAN and NCTR to investigate problems related to the interaction of UV with cosmetics. The program is expected to begin collaborating with CDER in the area of sunscreen testing, especially regarding UVA protection. The ionizing radiation program is expected to strengthen with the recent relocation to the White Oak campus where facilities will become available for the installation of upgraded ionizing radiation sources. Operating these new radiation sources is critical to the strengthening of the radiation bioeffects program. The program is thus becoming less involved with the risk assessment of electromagnetic fields (which formed the backbone of the program in the 1990s) and more oriented toward the radiation-emitting medical devices and consumer products, as well as the radiation-related issues in the area of counterterrorism. |
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Electrical, Electronics, and Software EngineeringScope This program, based in the Division of Electrical and Software Engineering, provides highly specialized technical support for Center and Agency regulatory activities in the areas of electrical/electronics engineering, software engineering, and systems engineering. While the bulk of our work in recent years has been in the medical device arena, the Division of Electrical and Software Engineering traces its roots to the Bureau of Radiological Health and continues to devote a portion of its efforts in support of the "rad health" mission of the Center. Background The program focuses on product realization, a term used by engineers to describe the process of converting a design concept into a viable product. Product realization encompasses all phases of the product life cycle and all aspects of the product manufacturers business, from research and development through procurement, production, and ongoing customer support. We examine the adequacy of the manufacturers documented processes, the extent to which the documented processes are being followed in practice and, in particular, the decisions arising from the application of those processes. We assure that the processes are grounded in established quality management and risk management principles, and that design decisions affecting safety and effectiveness of the product are consistent with established scientific and engineering principles. Our goal is to ensure that products consistently perform as intended, fulfilling the requirements of customers and other stakeholders. As a result, our program emphasizes analysis, laboratory testing, and educational activities over basic and applied research. Another important reason for this emphasis is that most regulatory issues involving electronics and/or software have historically arisen from misapplication of these technologies, rather than any inherent limitations. The research program currently focuses on two specific needs: objective methods to assess the performance of intelligent medical devices (specifically, those that provide clinical interpretation of physiological waveforms) and formal methods of software verification. The Division also routinely provides engineering support services to customers in CDRH, in other FDA Centers, and even external to FDA. These services include developing custom electronic instrumentation, designing and fabricating mechanical components and assemblies, procuring specialized electrical and electronic components, and maintaining and calibrating test equipment. Program Description Regulatory Support. While many groups within the Center have the need for electronics or software expertise, very few have sufficient need to justify a full-time engineering staff. By building a relatively small team of engineers who are highly qualified and making this critical mass of expertise available throughout the Center, OSEL is able to direct as much effort as needed to particular problems on an ad-hoc basis, thereby freeing the Center of the need to place engineering specialists in every Office of the Center. Centralizing the engineers in this fashion also facilitates communication and collaboration, ensuring that analyses and opinions rendered by the group have the benefit of extensive peer interaction and review. Furthermore, centralizing this function makes it possible to provide effective logistic support (laboratory facilities, supplies, test equipment, specialized software, and support personnel) to the team. Historically, many device problems arise at the confluence of hardware and software, the user, the manufacturing process, and the use environment. We apply a broad range of analytical tools to develop an understanding of these problems and engage the manufacturer in voluntarily seeking a solution. When the manufacturer is not responsive, we may test the device in question in our laboratory to develop evidence justifying unilateral action by FDA to remedy the problem. Education. Given the sheer numbers of medical devices that incorporate electronics and/or software, there is no practical way to ensure their safety and effectiveness through a program of retrospective reviews and inspections. Safety and effectiveness must be designed in by the manufacturer. Established manufacturers generally do a good job of this; but some manufacturers lack the requisite technical expertise and fail miserably. Over the long term, we believe that the principles and practices of product realization need to be better integrated into the core engineering curriculum at both the undergraduate and graduate levels. We have had some promising conversations with a number of educators and this is an initiative that bears further investment. Standards Development. Consensus standards represent another excellent tool for leveraging industry to improve the quality of medical devices, as well as streamlining the review process. Engineering Support Services. Originally, developing custom electronic instrumentation and test methods in support of FDA research and compliance activities was the principal mission of our staff. We have earned a number of patents for our innovative designs. Today, support services form a smaller, but still important, component of the mission. Research. The research program is aimed not at developing new technologies but at improving our capabilities in measurement and analysis. For example, our research involving test methods is aimed at improving FDAs ability to objectively compare the performance of diagnostic medical devices, even though those devices may use different modalities to sense the clinical conditions of interest. This is an avenue that medical device manufacturers are understandably reticent to pursue, even though it is clearly in the public interest to do so. Our research into formal methods of software verification, by contrast, is enthusiastically embraced by manufacturers because it will lead to tools that they can use for software development, help them to establish the safety and effectiveness of their devices, and streamline the regulatory approval process. Five-Year Objectives Expertise in the areas of software engineering and risk management is to be expanded since they are becoming of critical importance to the increasingly sophisticated medical devices for which the Center bears regulatory responsibility. Of particular importance is developing educational initiatives. OSEL believes that every CDRH and ORA employee should be familiar with the principles of quality management and risk management. Because of our systems engineering orientation, we have been at the forefront of efforts to increase staff awareness of these topics. Educational outreach to industry and academia is also being explored. In the risk management arena, investigations into methods for establishing acceptability criteria for evaluating risk, performing risk-benefit evaluations, using post-production information, and evaluating drug/device combinations must be initiated. Work is under way within CDRH to establish a uniform risk-based approach to device regulation. Guidance must be developed for performing risk management and reporting risk management results in pre-market submissions, establishing risk management as a component of a quality system, integrating risk management with design controls for both device design and design of manufacturing processes, and reconciling post-production information with prior risk management results. |
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Electromagnetics and Wireless TechnologiesScope This program focuses on the various issues associated with medical devices that utilize or are affected by electromagnetic (EM) fields. One issue is to address the rapid deployment of wireless technology around and into medical devices, and the safety and effectiveness concerns associated with electromagnetic interference (EMI) disruption of medical devices and the deposition of the electromagnetic energy in the human body. Another issue is to develop methods to evaluate medical devices used for ablation of body tissues and the measurement and evaluation of EM heating and the evaluation of devices used intentionally to hear (heat?) body tissues. A principle goal of this effort is to develop standard techniques for measuring and evaluating RF heating for both high- and low-frequency electromagnetic devices. Additionally, CDRH has the responsibility in the federal government to study and assess the risks of exposure to humans from electromagnetic non-ionizing radiation from radio frequency and microwave emitting electronic products. This is a complex and challenging field. OSEL scientists work vigilantly to stay abreast of the many hundreds of papers produced annually on this subject. The Division of Physics within OSEL performs measurements and dosimetry to evaluate the most common emitters of em fields, e.g., cellular phones and MRI devices. Background Responding to numerous adverse event and other reports, OSEL evaluated many types of medical devices for their susceptibility to interference from electromagnetic-field emitting sources such as wireless (cellular) telephones and magnetic-field emitting security devices. OSEL has already found the causes of several specific EMI problems and published results in peer reviewed literature. Additionally, OSEL was assigned by CDRH to lead the Centers Electromagnetic Compatibility (EMC) group that develops Center-wide EMC solutions for medical device EMI problems. In a separate but related area, CDRH has been involved in responding to a number of concerns expressed by numerous groups about the safety of human exposure to electromagnetic radiation emitted by hand-held wireless (cellular) telephones and other wireless devices. OSEL began addressing this issue by chairing or actively contributing to several international standards-setting groups. The groups are developing wireless phone measurement standards. A well-defined measurement standard is necessary if both the manufacturers of wireless devices and the regulatory agencies that protect public health are to agree on compliance with existing FDA and FCC radiation emission standards or set new standards for wireless devices. Further, research into the potential biological effects of non-ionizing RF radiation is highly dependent on the amount (dose) of absorbed RF radiation. Accurate and repeatable measurement of the RF radiation dose (dosimetry) is critical for laboratory and epidemiological studies. The thermal injury that results from tissue heating for electromagnetic devices needs to be tested. Given the wide variety of device designs and tissues in which the devices are used make it difficult to generalize the dosimetric and thermal heating patterns of medical devices. Finally, this program area develops standard techniques for measuring and evaluating RF heating for both high-and low-frequency electromagnetic devices. Program Description OSEL has an active ongoing program of testing high-risk medical devices for susceptibility to electromagnetic interference (EMI) emitted by a wide variety of common sources of electromagnetic fields. Examples of sources of EMI include wireless personal communications devices (e.g., cellular phones) and radio or TV broadcast towers. In addition to laboratory work, OSEL researchers routinely perform regulatory reviews of pre-market submissions awaiting approval by FDA as well as post-market assessments of EMI on medical devices. This program covers a wide range of medical device areas that include essentially all electrically powered devices, as well as the human exposures and energy deposition from a wide range of commonly used radio frequency emitters (e.g., cell phones, wireless computer links, security systems). The objective of the program is to develop independent data, measurement and computational techniques, and test methods that will serve as solid scientific foundations for regulatory guidance, proposals for national and international standards, and peer-reviewed technical publications. All of the work is driven to promote the public health by developing and coordinating vital information that is unavailable elsewhere. The program utilizes the unique OSEL expertise and facilities built-up over several years of successfully performing research and taking active leadership in addressing the hazards from medical device EMI and human exposure to electromagnetic non-ionizing energy. The wireless technology revolution, together with a flood of new medical devices incorporating sensitive microelectronics, is leading to a highly unstable situation. Dangerous malfunctions and numerous patient injuries have been induced in medical devices via electromagnetic interference (EMI) from electromagnetic fields emitted by wireless equipment. This equipment includes cellular phones, magnetic-field emitting security devices (such as airport metal detectors) and other medical devices such as shortwave diathermy and magnetic resonance imaging (MRI). OSEL leads the FDA effort to make all electrically powered medical devices electromagnetically compatible (EMC) with the electromagnetic environment where they are used. In addition to EMC, the public and news media continually express concerns about the possible harmful effects of exposure to radio frequency (RF) electromagnetic fields (also known as non-ionizing RF radiation) from hand-held wireless (cellular) telephones and other wireless personal communications devices. Five-Year Program Objectives OSEL will study the general issue of safety, data integrity, and risks to patients in the clinical or home being monitored by wireless medical device technology. Researchers will evaluate potential EMI/EMC problems associated with various wireless technology products (e.g., cellular phones, two-way radio transmitters) and wireless-connected palm/pocket computers that are increasingly being deployed in hospitals. It will also evaluate medical devices with wireless interfaces (Bluetooth, IEEE 802.11b) as sources and victims of EMI. OSEL scientists will also evaluate the measurement and computer modeling of human exposure to radio frequency non-ionizing radiation emitted by wireless electronic products worn on the body and others. In each of these areas, scientists will perform independent laboratory experiments and make measurements in the clinical environment to develop independent data on each subject area. This information will be disseminated in the form of peer-reviewed publications, input to national and international standards efforts, consultative regulatory reviews, and guidance documents. |
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Badano, Aldo, Ph.D. |
University of Michigan |
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Bassen, Howard I. |
University of Maryland Department of Biological Resources Engineering Lecturer George Washington University |
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Brown, Stanley A. |
University of Maryland Baltimore County (UMBC) Mechanical Engineering Adjunct Professor |
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Chenault, V. Michelle, Ph.D. |
Uniformed Services University of the Health Sciences Adjunct Assistant Professor |
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Das, Srilekha S., Ph.D. |
Henry M. Jackson Foundation for the Advancement of Military Medicine Guest Scientist |
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Goering, Peter L., Ph.D. |
University of Maryland School of Medicine Graduate Program in Toxicology Adjunct Professor George Washington University |
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Harris, Gerald R., Ph.D. |
Drexel University Department of Electrical and Computer Engineering Member, Doctoral Dissertation Committee |
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Hilbert, Stephen L., M.D., Ph.D. |
Brown University School of Medicine Department of Surgery Division of Cardiothoracic Surgery Adjunct Professor of Surgery (Research) |
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Karanian, John W., Ph.D. |
Georgetown University Medical Center Department of Physiology Adjunct Professor |
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Krauthamer, Victor, Ph.D. |
Uniformed Services University of the Health Sciences Department of Anatomy, Physiology and Genetics Adjunct Assistant Professor American University |
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Myers, Kyle J., Ph.D. |
Georgetown University Medical Center Department of Radiology Adjunct Associate Professor University of Arizona |
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Petrick, Nicholas, Ph.D. |
University of Michigan Department of Radiology Assistant Research Scientist |
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Valentine, Karen D. |
Montgomery College Department of Continuing Education Instructor/lecturer |
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Waynant, Ronald W., Ph.D. |
Catholic University of America Electrical Engineering Department Adjunct Associate Professor Uniformed Services University |
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Wear, Keith A., Ph. D. |
Georgetown University Department of Radiology Adjunct Professor Henry M. Jackson Foundation for the |
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AAMI | - American Association for Medical Instrumentation | |
AAPM | - American Association of Physicists in Medicine | |
ACCA | - Associate Commissioner for Consumer Affairs, OC, FDA, DHHS | |
ACF | - Administration for Children and Families, DHHS | |
ACCME | - Accreditation Council for Continuing Medical Education | |
ACHA | - Associate Commissioner for Health Affairs, OC, FDA, DHHS | |
ACLA | - Associate Commissioner for Legislative Affairs, OC, FDA, DHHS | |
ACMP | - American College of Medical Physicists | |
ACOM | - Associate Commissioner for Office of Management, OC, FDA | |
ACPA | - Associate Commissioner for Public Affairs, OC, FDA, DHHS (Press) | |
ACPE | - Associate Commissioner for Planning and Evaluation, OC, FDA, DHHS | |
ACPE | - American Council on Pharmaceutical Education | |
ACR | - American College of Radiology | |
ACRA | - Associate Commissioner for Regulatory Affairs, OC, FDA, DHHS | |
ADA | - American Dental Association | |
ADAMHA | - Alcohol, Drug Abuse, and Mental Health Administration, PHS, DHHS | |
AFGE | - American Federation of Government Employees (Union) | |
AFIP | - Armed Forces Institute of Pathology (located at WRAMC), DOD | |
AHA | - American Hospital Association | |
AHCPR | - Agency for Health Care Policy and Research, PHS, DHHS | |
AIMBE | - American Institute of Medical and Biological Engineering | |
AMA | - American Medical Association | |
ANSI | - American National Standards Institute | |
ARCRT | - American Registry of Clinical Radiography Technologists (MQSA) | |
ARPA | - Advanced Research Projects Agency | |
ARRT | - American Registry of Radiologic Technologists (MQSA) | |
ASH | - Assistant Secretary for Health, DHHS | |
ASPE | - Assistant Secretary for Planning and Evaluation, DHHS | |
ASPER | - Assistant Secretary for Personnel Administration, DHHS | |
ASTM | - American Society for Testing and Materials | |
BRMD | - Bureau of Radiation and Medical Devices, CANADA | |
CBER | - Center for Biologics Evaluation and Research, FDA, DHHS | |
CC | - Clinical Center (Warren Magnuson Clinical Center), NIH, DHHS | |
CEU | - Continuing Education Unit | |
CDC/CDCP | - Centers for Disease Control/Centers for Disease Control and Prevention | |
CENELEC | - European Committee for Electrotechnical Standardization (French term, English translation) | |
CDER | - Center for Drug Evaluation and Research, FDA, DHHS | |
CDRH | - Center for Devices and Radiological Health, FDA, DHHS | |
CFSAN | - Center for Food Safety and Applied Nutrition, FDA, DHHS | |
CIA | - U.S. Central Intelligence Agency (Headquarters: Arlington, VA) | |
CIRMS | - Council on Ionizing Radiation Measurements and Standards, NIST | |
CLIA | - Clinical Laboratory Improvement Amendments of 1988 | |
CME | - Continuing Medical Education | |
CRADA | - Cooperative Research and Development Agreement | |
CRCPD | - Conference of Radiation Control Program Directors | |
CTIA | - Cellular Telephone Industry Association | |
CVM | - Center for Veterinary Medicine, FDA, DHHS | |
DASH | - Deputy Assistant Secretary for Health, OASH, DHHS | |
DCP | - Division of Commissioned Personnel, OASH, OSG (Parklawn Building) | |
DHHS | - U.S. Department of Health and Human Services | |
DHSS | - Department of Health and Social Security, ENGLAND | |
DOC | - U.S. Department of Commerce | |
DOD | - U.S. Department of Defense | |
DOL | - U.S. Department of Labor | |
DOE | - U.S. Department of Energy | |
DOT | - U.S. Department of Transportation | |
ECRI | - Emergency Care Research Institute (no longer uses nameinitials only) | |
EEO | - Equal Employment Opportunity Act | |
EMBS | - Engineering in Medicine and Biology Society, IEEE | |
ERIM | - Environmental Research Institute of Michigan | |
FAA | - Federal Aeronautics Administration | |
FBI | - Federal Bureau of Investigation, Department of Justice | |
FCC | - Federal Communications Commission | |
FCCSET | - Federal Coordinating Council for Science, Engineering and Technology, | |
FIC | - Fogarty International Center, NIH, DHHS | |
FDA | - U.S. Food and Drug Administration, PHS, DHHS | |
FDAMA | - Food and Drug Administration Modernization Act of 1997 | |
FDLI | - Food and Drug Law Institute | |
FOIA | - Freedom of Information Act | |
FTC | - U.S. Federal Trade Commission | |
GAO | - General Accounting Office | |
GC | - General Counsel, FDA (now Office of Chief Counsel, FDA) | |
GPRA | - Government Performance and Results Act | |
GPRE | - Government Program Review and Evaluation | |
GSA | - General Services Administration | |
HCFA | - Health Care Financing Administration | |
HIMA | - Health Industry Manufacturers Association | |
HRG | - Health Research Group (Public Citizen: Ralph Nader-Dr.
Sidney Wolfe) (Consumers Health Political Action Committee - PAC) |
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HRSA | - Health Resources and Services Administration, PHS, DHHS | |
ICRP | - International Commission on Radiological Protection | |
ICRU | - International Commission on Radiation Units and Measurements | |
IEC | - International Electrotechnical Commission | |
IEEE | - Institute of Electrical and Electronic Engineers, Inc. | |
IFIP | - International Federation for Information Processing | |
IG | - Inspector General, OIG, DHHS | |
IHS | - Indian Health Service, DHHS | |
INNS | - International Neural Networks Society | |
INS | - U.S. Immigration and Naturalization Service | |
IOM | - Institute of Medicine, NAS | |
IRB | - Institutional Review Board | |
IRS | - U.S. Internal Revenue Service | |
ISO | - International Standards Organization | |
JCAHCA | - Joint Commission on Accreditation of Health Care Organizations | |
MDUFMA | - Medical Device User Fee and Modernization Act of 2002 | |
NAAP | - National Association of Apnea Professionals | |
NAS | - National Academy of Sciences | |
NBS | - National Bureau of Standards, DOC (No longer exists: See NIST), | |
NCCLS | - National Committee for Clinical Laboratory Science | |
NCHS | - National Center for Health Statistics, CDCP, DHHS | |
NCHGR | - National Center for Human Genome Research, NIH, DHHS | |
NCI | - National Cancer Institute, NIH, DHHS | |
NCNR | - National Center for Nursing Research, NIH, DHHS | |
NCRP | - National Council on Radiation Protection | |
NCTR | - National Center for Toxicological Research, FDA, DHHS | |
NEI | - National Eye Institute, NIH, DHHS | |
NEMA | - National Electrical Manufacturers Association | |
NHLBI | - National Heart, Lung, and Blood Institute, NIH, DHHS | |
NIA | - National Institute on Aging, NIH, DHHS | |
NIAAA | - National Institute on Alcohol Abuse and Alcoholism, NIH, DHHS | |
NIAID | - National Institute of Allergy and Infectious Diseases, NIH, DHHS | |
NIAMSK | - National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, DHHS | |
NICHHD | - National Institute of Child Health and Human Development, NIH, | |
NIDCD | - National Institute on Deafness and Other Communication Disorders, NIH, DHHS NIDA | |
NIDA | - National Institute on Drug Abuse, NIH, DHHS | |
NIDDKD | - National Institute of Diabetes and Digestive and Kidney Diseases, NIH NIDR - National Institute of Dental Research, NIH, DHHS | |
NIEHS | - National Institute of Environmental Health Sciences, NIH, DHHS | |
NIGMS | - National Institute of General Medical Sciences, NIH, DHHS | |
NIMH | - National Institute of Mental Health, NIH, DHHS | |
NINDS | - National Institute of Neurological Disorders and Stroke, NIH, DHHS | |
NIH | - National Institutes of Health | |
NIOSH | - National Institute for Occupational Safety and Health, CDCP, DHHS | |
NIST | - National Institute of Standards and Technology, DOC (formerly NBS) | |
NLM | - National Library of Medicine, NIH, DHHS | |
NMQAAC | - National Mammography Quality Assurance Advisory Committee, FDA | |
NRC | - National Research Council | |
NRC | - U.S. Nuclear Regulatory Commission | |
NSA | - U.S. National Security Agency (Headquarters: Fort Meade, MD) | |
NSF | - National Science Foundation | |
NOAA | - National Oceanographic and Atmospheric Administration | |
NVLAP | - National Association of Voluntary Laboratory Accreditation Practices | |
OC | - Office of the Commissioner, FDA | |
OCA | - U.S. Office of Consumer Affairs | |
OCC | - Office of the Chief Counsel, FDA (formerly OGC) | |
OCR | - Office for Civil Rights, DHHS | |
OHA | - Office of Health Affairs, FDA, DHHS | |
OIG | - Office of the Inspector General | |
OLA | - Office of Legislative Affairs, OC, FDA, DHHS | |
OMB | - Office of Management and Budget | |
OPA | - Office of Public Affairs, OC, FDA, DHHS (Press Office/Relations) | |
OPE | - Office of Planning and Evaluation, FDA, DHHS | |
ORA | - Office of Regulatory Affairs, FDA, DHHS | |
OPM | - Office of Personnel Management | |
OS | - Office of Secretary, DHHS | |
OSG | - Office of the Surgeon General, PHS, DHHS (Commissioned Corps) | |
OSHA | - Occupational Safety and Health Administration | |
PAC | - Political Action Committee | |
PAHO | - Pan-American Health Organization, WHO, UN | |
PHS | - U.S. Public Health Service | |
RESNA | - Rehabilitation Engineering Society of North America, ANSI | |
RSNA | - Radiological Society of North America | |
SAMHSA | - Substance Abuse and Mental Health Services Administration, DHHS | |
SCVIR | - Society for Cardiovascular and Interventional Radiology | |
SMDA | - Safe Medical Devices Act of 1990 | |
SNL | - Sandia National Laboratories | |
SPIE | - Society of Photo-Optical Instrumentation Engineers | |
SSA | - Social Security Administration (formerly part of DHHS) | |
SSRCR | - Suggested State Regulations for Control of Radiation | |
UL | - Underwriters Laboratories | |
UN | - United Nations | |
USDA | - U.S. Department of Agriculture | |
WCNN | - World Congress of Neural Networks | |
WEAC | - Winchester Engineering and Analytical Center, FDA, DHHS | |
WHO | - World Health Organization, UN | |
WRAIR | - Walter Reed Army Institute of Research, WRAMC, U.S. Army | |
WRAMC | - Walter Reed Army Medical Center, U.S. Army | |
CDRH ABBREVIATIONS AND ACRONYMS |
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DB |
- Division of Biology |
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DCLD | - DivisonDivision of Clinical Laboratory Devices, ODE | |
DCMS | - Division of Chemistry and Materials Sciences | |
DCRND | - Division of Cardiovascular, Respiratory and Neurological Devices, ODE | |
DDL | - Devices and Diagnostics Letter (also known as The Orange Sheet) (Weekly Trade Magazine) | |
DECS | - Division of Electronics and Computer Science, OST | |
DESE | - Division of Electronics and Software Engineering | |
DGRD | - Division of General and Restorative Devices, ODE | |
DIAM | - Division of Imaging and Applied Mathematics | |
DLS | - Division of Life Sciences, OST | |
DMISS | - Division of Management, Information and Support Services, OST | |
DMMS | - Division of Mechanics and Materials Science, OST | |
DMQRP | - Division of Mammography Quality and Radiation Programs, OHIP | |
DOD | - Division of Ophthalmic Devices, ODE | |
DP | - Division of Physics | |
DPS | - Division of Physical Sciences, OST | |
DRAERD | - Division of Reproductive, Abdominal, ENT, & Radiological Devices, ODE EIR - Establishment Inspection Report | |
DSFM | - Division of Solid and Fluid Mechanics | |
EMC | - Electromagnetic Capability | |
EMI | - Electromagnetic Interference | |
ERC | - NSF Engineering Research Center, Duke University (National Science Foundation) | |
510(k) | - Five-Ten K: Pre-market Notification of New Medical Device
(Clearance Based on a Similar, Previously Cleared Device) |
|
HL | - High Level or High-Level Control | |
IDE | - Investigational Device Exemption | |
IND | - Investigational New Device (or Drug) (application for transitional devices) | |
IAG | - Interagency Agreement | |
kVp | - Measurement of Meters (as in kVp Meters) | |
MDDI | - Medical Devices, Diagnostics & Instrumentation (also known as The Gray Sheet) (Weekly Trade Magazine)) | |
MDH | - X-ray radiation instrument used by FDA in its inspections (originally marketed by a company called MDH) | |
MDR | - Mandatory Device Reporting Program | |
MON | - Memorandum (Memoranda) of Need | |
MQC | - Mammography Quality Control (as in MQC Manual) | |
MQSA | - Mammography Quality Standards Act of 1992 | |
MRI | - Magnetic Resonance Imaging (formerly nuclear magnetic resonance) | |
MRS | - Magnetic Resonance Spectroscopy | |
NEXT | - Nationwide Evaluation X-ray Trends (Data Bank) | |
NSWL | - Naval Surface Warfare Laboratory (in White Oak, Silver Spring) | |
NVLAP | - National Voluntary Laboratory Accredited Program, (NIST, DOC) (MQSA) | |
OC | - Office of Compliance, CDRH, FDA | |
OCD | - Office of the Center Director, CDRH, FDA, DHHS | |
ODE | - Office of Device Evaluation, CDRH, FDA | |
OHIP | - Office of Health and Industry Programs, CDRH, FDA | |
OSM | - Office of Systems and Management, CDRH, FDA | |
OPA | - Office of Public Affairs, FDA, DHHS (Press Office) | |
ORA | - Office of Regulatory Affairs, FDA, DHHS (field offices) | |
OSB | - Office of Surveillance and Biometrics, CDRH, FDA | |
OST | - Office of Science and Technology, CDRH, FDA | |
PDP | - Product Development Protocol | |
PMA/PMAA | - Pre-Market Approval Application | |
PMS | - Post-Market Surveillance | |
QA | - Quality Assurance | |
QC | - Quality Control | |
RIHSC | - Research Involving Human Subjects Committee, FDA | |
ROC | - Receiver Operating Characteristic Curve | |
RRHR | - Regional Radiological Health Representative, FDA | |
SCLIR | - Secondary Calibration Laboratories for Ionizing Radiation | |
SIDS | - Sudden Infant Death Syndrome | |
TEPRSSC | - Technical Electronic Product Radiation Safety Standards Committee, CDRH, FDA, DHHS | |
TMJ | - Temporomandibular Joint | |
TQM | - Total Quality Management |
Updated January 27, 2005
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