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U.S. Department of Health and Human Services

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FY 2006 OSEL Division Descriptions

DIVISION OF BIOLOGY (DB)

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 Center’s 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 Center’s enforcement and product testing activities.

The DB staff members are primarily biologists, chemists, and biomaterials scientists.

Laboratories

  • Biological Risk Assessment
  • Biotechnology
  • Biomolecular Mechanisms
  • Cardiovascular and Interventional Therapies
  • Radiation Biology
  • Toxicology

DIVISION OF CHEMISTRY AND MATERIALS SCIENCES (DCMS)

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.

Laboratories

  • Active Materials
  • Experimental Pathology
  • Materials Performance

DIVISION OF ELECTRICAL AND SOFTWARE ENGINEERING (DESE)

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 manufacturer’s 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.

Laboratories

  • Electrical Engineering
  • Software
  • Systems Engineering

DIVISION OF IMAGING AND APPLIED MATHEMATICS (DIAM)

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.

Laboratories

  • Image Analysis
  • Imaging Physics
  • Ionizing Radiation Metrology

DIVISION OF PHYSICS (DP)

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 Center’s 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 Center’s 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.

Laboratories

  • Electrophysiology and Electrical Stimulation
  • Electromagnetic and Wireless Technology
  • Optical Diagnosis
  • Optical Therapeutics and Medical Nanophotonics

DIVISION OF SOLID AND FLUID MECHANICS (DSFM)

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.

Laboratories

  • Fluid Dynamics
  • Mechanics
  • Ultrasonics

STANDARDS MANAGEMENT STAFF (SMS)

The SMS is responsible for managing the Center’s standards program. The staff in this program is responsible for developing, managing, and supporting standards used for regulatory assessments. SMS supports participation in medical device standards committees. The staff accomplishes these tasks with the help of Standards Task Groups (STGs). 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.

MANAGEMENT SUPPORT STAFF (MSS)

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) responsibility for the office. The KMS team provides technical support for the acquisition, retrieval, and analyses of data supporting the office’s 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.