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.
- Biological Risk Assessment
- Biomolecular Mechanisms
- Cardiovascular and Interventional Therapies
- Radiation Biology
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.
- Active Materials
- 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.
- Electrical Engineering
- 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.
- Image Analysis
- Imaging Diagnostics
- 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.
- Electrophysiology and Electrical Stimulation
- Electromagnetic and Wireless Technology
- Optical Therapeutic Devices
- 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.
- Fluid Dynamics
- Solid Mechanics
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.
The MSS team collaborates with the Center and Agency Information Management offices in implementing major information technology 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.
Office of Science and Engineering Laboratories
Active Materials (Division of Chemistry and Materials Sciences)
Scientists in the Active Materials Laboratory investigate materials used in devices in which the time dependence of materials properties is a key component of how the device's mode of action is provided. This includes combination products in which medical devices incorporate some material-based mechanism for drug delivery, such as drug eluting stents. It also includes nano-materials, in which the properties of the nano-particles are critical to delivery of expected results.
Biological Risk Assessment (Division of Biology)
Risk assessment is the process of determining the extent of human health hazard relative to exposure conditions. Staff in the OSEL Laboratory of Biological Risk Assessment: 1) conduct research to address CDRH’s regulatory need for improved methods of detecting and quantifying risks associated with chemical compounds, microbial agents, and radiation released from medical device materials; and 2) conduct risk assessments to inform risk management decisions in the Center. Research is focused the following areas:
- Safety of reprocessed medical devices: Research in this area includes the assessment of the toxicity of residual disinfectants/sterilants and the efficacy of methods to remove residual bioburden on reprocessed devices.
- Development of clinically relevant biomarkers and preclinical animal models: Research in this area was identified as being central to the FDA Critical Path Initiative.
- Bioeffects of ultrasound and ultrasound contrast agents: Involves an assessment of the extent of the vascular endothelial and smooth muscle damage by microbubble-based ultrasound contrast agents and its role in the pathogenesis atherosclerotic changes.
Biomolecular Mechanisms (Division of Biology)
New genomic and genetic technologies are expected to impact CDRH in major ways. The Center is beginning to receive submissions of genomic and genetic diagnostic microarray devices and expects more--some in co-development with drug or biological therapeutics. In addition, these technologies will be used to evaluate the safety of products such as implants and materials (toxico-genomics). However, considerable technical uncertainties impede the acceptance of these products and data. The Genomics Laboratory is providing support to the Center via 1) prioritization of the technical issues affecting microarray data that impact product review, and 2) application of the new technologies to both new and long-standing problems, including medical device adverse events, identification of medical device pathogen contaminants, and safety evaluation of products. Additionally, the Cell Biology Laboratory is investigating immunotoxicity related to particular patient susceptibility, in regards to biomaterials and devices that contact patient blood.
Biotechnology (Division of Biology)
The biotechnology laboratory’s mission is to study various aspects of microbial pathogen contamination of medical devices and to reduce the risk of microbial infection from contaminated medical devices and to study the biocompatibility of nanoparticles. The laboratory’s main research projects are focused on evaluation of nanoparticles properties and on microbial detection and analysis, using an interdisciplinary research approach that integrates engineering and molecular biology.
Cardiovascular and Interventional Therapeutics (Division of Biology)
The Laboratory of Cardiovascular and Interventional Therapeutics (LCIT) investigates the safety and effectiveness of a range of interventional therapeutics, including cardiovascular and minimally invasive devices and related adjunctive agents. This includes the application of emerging imaging technologies to guide the delivery of novel therapeutic devices and agents. Local delivery of therapeutic devices alone or in combination with other agents via percutaneous catheters or direct surgical access has shown great clinical promise for the treatment and prevention of vascular disease and cancer. The laboratory’s Research Program includes both normal biology and the pathologic basis for disease and device failure at the genetic, molecular and tissue levels and the development of animal models that are predictive of clinical safety and effectiveness.
The focus is on studying existing models and developing more predictive models of device use and related failure modes including identification, evaluation and development of more optimal clinical treatment algorithms for image-guided interventions and drug delivery, such as tumor ablation. In addition, retrospectively, the models have been used to support applications for vascular devices. The in vivo models under study include both normal swine and swine models of human disease, i.e., those with vasculopathy induced by diet (atherogenic high fat/high cholesterol diets), mechanical manipulation (iatrogenic injury from balloon angioplasty or stenting), hormonal manipulation (castration, hormone replacement therapy), hemodynamic alterations (vascular ligation, fistulas) and/or metabolic manipulation (diabetes mellitus). These preclinical animal studies address the problem of identifying and assessing regulatory science issues associated with novel interventional and combination therapeutics and delivery technology including image guidance tools for the treatment of vascular disease and cancer.
Electrical Engineering (Division of Electrical and Software Engineering)
Electrical engineering is an enabling technology for many, if not most, classes of medical devices. Devices that incorporate this technology are inherently complex and require that engineers must be able to skillfully peel back many layers of abstraction from the underlying mathematical and physical models that govern device operation, to their hardware and software realizations, and down to the physical characteristics of component parts.
A large body of knowledge has developed within the electronics, embedded software, and systems engineering communities to assure successful application of these technologies. The mission of the Electrical Engineering Laboratory is to apply this body of knowledge to the regulation of electronic medical devices and electronic products that emit radiation.
The breadth of the engineering disciplines needed poses a significant challenge. The body of knowledge is segmented into numerous areas of specialization, power engineering, electromagnetic and static immunity, microminiaturization and signal processing. Within industry, large manufacturers typically have sizable organizational components to address those engineering segments (specialties) having most relevance to their needs. Small manufacturers typically have specialists in just a few key areas and rely on consultants or other external resources to augment their in-house capabilities.
We maintain a suite of special-purpose, computer-aided engineering tools and laboratory facilities having broad applicability to medical device electronics and embedded software and we rely on external sources for specialized capabilities that are needed on an occasional basis.
Electromagnetic and Wireless Technologies (Division of Physics)
Research is focused on several concerns associated with medical devices that utilize or are affected by electromagnetic (EM) fields. The primary concern is to address the rapid deployment of wireless technology around and into medical devices, and to address the safety and effectiveness issues associated with electromagnetic interference (EMI) disruption of medical devices and the deposition of the electromagnetic energy in the human body. Another concern 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 body tissues. A principle goal of this effort is to develop standard techniques for the measurement and evaluation of RF heating for both high and low frequency electromagnetic devices. A third area involves the safety of patients undergoing magnetic resonance imaging procedures. Patients with implanted devices, and electrodes or other devices attached to the body, are being imaged by MRI, and some are being injured or even killed due to heating from the intense EM fields produced by the radiofrequency (RF) coils during clinical imaging procedures. Medical device manufacturers are submitting requests for approval of their devices as MRI compatible, e.g., allowed to be in or attached to the patient during MR imaging procedures
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), radiofrequency identification (RFID) systems and other medical devices such as shortwave diathermy and magnetic resonance imaging (MRI). DP 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, concerns are continually raised by the public and the news media about the possible harmful effects of exposure to radio frequency (RF) electromagnetic fields (also known as non-ionizing RF radiation) from handheld wireless (cellular) telephones and other wireless personal communications devices.
Electrophysiology and Electrical Stimulation (Division of Physics)
Medical devices that rely on electrophysiology and electrical stimulation for safety and efficacy cut across all medical specialties. The most important examples are devices that work in the heart and nervous system including the following: cardiac pacemakers, defibrillators, retinal stimulators for blindness, brain stimulators (for Parkinson’s disease, pain, motor function, hearing), electroconvulsive therapy, magnetic brain stimulation, cochlear implants, middle ear hearing devices, spinal cord stimulators, vagus nerve stimulators, and peripheral nerve stimulators (including those for locomotion, breathing, bladder and bowel control). The less obvious examples are devices for the electrical detection of cancer (from breast, colon and cervix), the transdermal electrical extraction of glucose for monitoring, and a number of “complementary and alternative medicine” devices. The scientific discipline of electrophysiology forms a unified basis for the scientific evaluation of all of these devices. The scientific issues involve the basic electrophysiology of a number of body systems and the biomedical engineering of the devices.
The work ranges from research directly applied to a single device type (the retinal stimulator), to broader work that is relevant to a class of devices (cardiac stimulators for treating arrhythmias and heart failure), to far-reaching work on the development of optical stimulation of excitable tissue (supported extramurally). In addition to these areas of research, this laboratory is heavily involved in direct regulatory activities with staff performing as lead reviewers, expert consultants, subject matter experts to FDA Advisory Panels, authors of guidance documents and the revision of international medical device standards.
Fluid Dynamics (Division of Solid and Fluid Mechanics)
Fluid dynamics, as it applies to medical devices, can be broadly defined as the interaction of moving fluids with medical devices: both as the device affects the moving fluid and as the moving fluid affects the device. Often the moving fluid is blood, as in the flow of blood through a heart valve or through the filters and pumps of a renal dialysis apparatus. Damage to the flowing blood can result in serious clinical consequences, up to and including death. Damage to a device, such as might be caused by cavitation in a heart valve, can lead to catastrophic device failure causing death. Accordingly, the Laboratory of Fluid Dynamics, located in the Division of Solid and Fluid Mechanics, maintains a research program focused on the fundamental factors governing the interaction of flowing fluids with medical devices and the development of test methodologies to objectively characterize such interactions and their consequences.
Image Analysis (Division of Imaging and Applied Mathematics)
A wide variety of new digital imaging and display devices is under development by academia and industry, with a broad range of performance characteristics. The Center requires augmented support for the evaluation of such devices. To this end, OSEL scientists in this laboratory are developing a fundamental understanding of how these new devices operate and are developing a unified methodological approach for validating the applicability of these new diagnostic medical systems. The emphasis of the Image Analysis Laboratory is to understand the building block of computer software tools and developing assessment methodologies that appropriately estimate performance and improve clinical and non-clinical trail designs. Application areas include mammography, optical imaging, computed tomography, nuclear medicine, immunohistochemistry, computer-aided diagnosis, and gene expression. This program is located within the Division of Imaging and Applied Mathematics (DIAM).
Imaging Diagnostics (Division of Imaging and Applied Mathematics)
A wide variety of new advanced imaging systems with solid state detectors and digital display devices are under development by academia and industry, with a broad range of performance characteristics. To support the Center’s need for assistance evaluating such devices, 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 for novel soft-copy display devices for viewing medical images. This program is located within the Division of Imaging and Applied Mathematics (DIAM).
Ionizing Radiation Measurements Laboratory (Division of Imaging and Applied Mathematics)
The scope of the Ionizing Radiation Measurements Laboratory ( IRML) is to provide metrology support to the Center’s Radiological Health and Medical Device safety mission. IRML maintains measurement and calibration capabilities for ionizing radiation. The ISO17025-compliant laboratory provides traceability for standards-enforcement measurements, provides metrology expertise for pre- and post-market issues, performs evaluations of x-ray emissions from regulated products, performs evaluations of measurement methods, and represents the Center on appropriate consensus standards efforts.
Materials Performance (Division of Chemistry and Materials Sciences)
Scientists in the Materials Performance Laboratory investigate materials used in devices in which the physical/chemical properties of a material impact its performance and the long-term behavior of these properties affect the device's safety or effectiveness. For example, the long-term performance of implanted electronic devices, such as cochlear implants or pacemakers, depends on the continued hermiticity of the devices' casings. Intraocular lenses used in cataract and other surgeries need to maintain their optical properties over time. Finally, mechanical performance and degradation of hydrogel materials, such as hyaluronic acid, may affect the safety and effectiveness of adhesion barriers and other devices.
The use of new materials and processing technologies is a challenge to the regulation of new medical devices. The knowledge gap between the Center’s understandings of existing materials used in devices evolving technologies will tend to increase the time required for the review of these submissions, as our staff “comes up to speed” in these areas. Through directed research activities, it is the goal of this laboratory to develop such expertise and insights into the behavior of new materials used in devices and the effects of manufacturing on their safety and efficacy.
Optical Diagnostics (Division of Physics)
The rapid proliferation of medical devices employing minimally invasive optical technology is revolutionizing modern health care. However, these devices also represent a significant new challenge to FDA. For many of these devices, guidance documents and reliable test methods are currently not available. Basic mechanism data is needed to facilitate the development of relevant evaluation criteria early in the regulatory process, thus enabling thorough and swift reviews of this cutting edge technology. The Optical Diagnostics laboratory works to generate this data through studies of light-tissue interaction mechanisms, device performance and tissue safety for a variety of optical technologies. This program is located within the Division of Physics (DP).
Optical Therapeutic and Medical Nanophotonics (Division of Physics)
Biophotonics is an emerging biomedical technology that is increasingly being applied in the extensive areas of life sciences and medicine. Minimally invasive biophotonics techniques have been recently developed as potential alternatives to conventional medical methods for diagnostics, monitoring and treatment of a variety of diseases, drug discovery, proteomics, and environmental detection of biological agents. These techniques offer a non-contact, effective, fast and painless way for sensing and monitoring of various biomedical quantities. Medical devices utilizing minimally invasive biophotonics technology are rapidly finding their way into the mainstream for early disease diagnosis and improved patient acceptance and comfort.
The Optical Therapeutics and Medical Nanophotonics Laboratory (OTMNLab) was established as part of OSEL’s Division of Physics in September 2006. OTMNLab is responsible for maintaining state-of-the-art knowledge of biomedical optics and laser field to assist the Center and Agency in the following:
- Evaluating new medical therapeutics devices that employ the latest minimally invasive medical laser technology.
- Evaluating critical fundamental parameters of key laser and fiber-optic components employed in recently developed optical therapeutics devices.
Radiation Biology (Division of Biology)
This laboratory conducts research to investigate the public health impact of electromagnetic radiation exposure from medical devices and non-medical electronic products.
Current efforts are directed toward better understanding of the risks of non-ionizing radiations from wireless telecommunication devices, assessing the skin cancer problem associated with use of tanning lamps, and quantifying the differences in UV response in differently pigmented populations in the U.S. Also, in line with the Center’s initiative to focus on the most pressing radiological problems and to anticipate the evolution of new medical radiation systems, we continue to concentrate our research efforts in ionizing radiation to better understand radiation-drug and radiation-heat interactions, and to provide the Center with expertise on a new class of low dose x-ray therapeutic devices entering the market. The laboratory also monitors the scientific literature and maintains expertise in other radiation areas, such as laser, visible, and extremely low-frequency radiation.
Software (Division of Electrical and Software Engineering)
The scope of this laboratory’s activities is to support CDRH pre-market and post-market software evaluation activities by establishing relevant in-house expertise and identifying, qualifying, quantifying, and communicating conformity assessment techniques and criteria which the Center can use to fulfill its mission.
Software is one of the most ubiquitous enabling technologies for many, if not most, classes of medical devices. Devices that incorporate this technology are inherently extremely complex and require that engineers must be able to skillfully peel back many layers of abstraction from the underlying mathematical, behavioral and physical models that govern device operation, to their hardware and software realizations, and down to the physical characteristics of component parts.
A large body of knowledge has developed within the software engineering community, embedded software industry, and systems engineering communities to assure successful application of these technologies. The mission of the DESE Software Laboratory is to apply this body of knowledge to the regulation of electronic medical devices and electronic products that emit radiation.
An essential element of the program is to identify and develop in-house specialized analytical tools and laboratory facilities. We maintain a suite of special-purpose, computer-aided verification tools and laboratory facilities having broad applicability to medical device software and embedded software, and we continue to leverage external sources for specialized capabilities that are needed on an occasional basis.
Systems Engineering (Division of Electrical and Software Engineering)
This laboratory applies a systems engineering perspective to medical device regulatory issues.
With the advent of systems of devices, closed-loop devices, and intelligent devices, the fabric of regulation and FDA’s historic enforcement discretion policy needs to be continually revisited to determine its ongoing ability to get as many safe systems to market and to allow them to remain safe while there. The expertise developed through this laboratory is being used to educate reviewers across the Center and provide a basis for the evaluation and drafting of new classification regulations, guidance documents and enforcement policy.
Toxicology (Division of Biology)
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. Researchers evaluate the potential adverse effects of medical device materials and chemicals, including nano-sized particles, using in vivo and in vitro experimental models and approaches. Scientists use data to reduce uncertainties in assessing risks to patients exposed to physical and chemical exposures, and ultimately protect their health.
A primary focus of the program in 2006-07 was evaluating bioeffects of nanoparticles. The unique properties of nanoparticles (very small size, large surface area, increased biological activity) drive the current explosion in nanotechnology innovation in health care delivery. FDA-regulated products expected to utilize nanotechnology include implants and prosthetics, sensors for disease diagnosis, and drug delivery and personal care products. In contrast, these same properties may impart negative or undesirable effects on biological systems. Attempts to understand the potential adverse effects of nanoparticles are limited, and very few resources have been committed to research needed to address and understand risks to patients.
Ultrasonics (Division of Solid and Fluid Mechanics)
Medical ultrasound spans a wide array of diagnostic, therapeutic, and surgical applications. An important part of establishing the safety and effectiveness of these devices is acquiring accurate and meaningful pre-clinical performance information. Therefore, to support the regulatory review of these products, the Ultrasonics Laboratory, located in the Division of Solid and Fluid Mechanics, maintains a research program devoted to exposure measurement and analysis, and guidance and standards development.
The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards. CDRH is invested in the development of medical device standards and participates significantly in the development process. SMS manages the Standards Program, a regulatory support activity consisting of cross-office teams within CDRH and FDA. 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. SMS also participates in the coordination of GHTF activities. The GHTF was formed in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems.
SMS continually updates currently recognized standards and coordinates the recognition of new voluntary consensus standards for medical devices and radiation-emitting electronic products. SMS ensures appropriate medical device standards are published in the Federal Register at least twice annually and maintains an electronic database for easy access. 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. Please refer to the CDRH Standards web page for additional information.
Recognized Standards for 2007
- 73 new standards
- 120 standards that were withdrawn and new versions were recognized
- 241 changes to the existing recognized standards
- 35 standards were withdrawn
Radiology. The recognition of two radiology standards: NEMA XR 22-2006, “Quality Control Manual” Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography and NEMA XR 23-2006, “Quality Control Manual” Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography is important for 2007. Mammography remains the best method of early breast cancer detection. However, traditional film-screen mammography is limited in its ability to detect some cancers, especially those occurring in women with radiographically “dense" breasts.” For this reason, extensive research efforts to improve mammography have occurred. Digital mammography offers theoretical advantages compared to film-screen mammography for cancer detection. These standards define the minimum set of quality control tests which manufacturers should include as part of the quality assurance plan for the Full Field Digital Mammography System.
Ophthalmics Instruments. The recognition of - ISO 15004-2:2007 Ophthalmic Instruments - Fundamental requirements and test methods Part 2: Light hazard protection - is an important ophthalmic standard recognition for 2007. An example of one medical device in this area would be the ophthalmoscope, which is a device containing illumination and viewing optics to examine the cornea, aqueous, lens, vitreous, and the retina of the eye. This standard specifies fundamental requirements for optical radiation safety for ophthalmic instruments such as the ophthalmoscope and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye.
Steam sterilization in health care facilities. The recognition of ANSI/AAMI ST79:2006 Comprehensive guide to steam sterilization and sterility assurance in health care facilities combined five standards into one comprehensive standard. This standard is intended to promote sterility assurance and to guide health care personnel in the proper use of processing equipment. Included within the scope of the recommended practice are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas); staff qualifications, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement.
Lasers and laser-related equipment. The recognition of ISO 11810-2:2007--Lasers and laser-related equipment: Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers -- Part 2: Secondary ignition. This standard is an important recognition for 2007. The use of surgical lasers offers the medical community distinct advantages in the operating room. Although laser surgery affords the public improved health care, the use of lasers present new hazards in the operating room environment. Despite efforts to confine laser beams to the intended operative site, lasers can and inadvertently do sometime become focused on unintended locations, either as the direct laser beam or as stray light from the beam. This has resulted in burns, permanent eye damage, fires and, in some instances, death. All materials reflect portions of the beam, and it is necessary for the user to decide whether specular reflection may be a hazard. The purpose of ISO 11810-2:2007 is to provide a standardized method for testing and classifying surgical drapes and/or patient protective covers with respect to laser-induced hazards. ISO 11810-2:2007 is applicable to disposable and re-usable, as well as woven and non-woven materials, used as surgical drapes and/or patient protective covers which claim to be laser-resistant.
Software/Informatics. Due to the increasing emphasis in informatics and the relationship between informatics and software, the name for the Software STG was changed to the Software/Informatics STG. This change was vital to keep our program current with changes in medical devices.
17 th Annual AAMI/FDA International Conference on Medical Device Standards and Regulation. The conference is sponsored jointly by the Association for the Advancement of Medical Instrumentation and the U.S. Food and Drug Administration. It provided detailed information about the latest standards and regulatory initiatives that affect manufacturers of medical devices — both in the U.S. and overseas. As an annual co-sponsor of this significant conference, Carol Herman, Director of the Standards Management Staff, helped develop the agenda and identify appropriate speakers. There were eight speakers from FDA/CDRH, with topics covering risk management, global harmonization, the CDRH ombudsman and other important areas. Nearly 200 participants attended the conference representing the medical device industry and FDA staff.
The Standards Study. The studies goal was to review the utilization of standards in the pre-market review program, to determine if there was added value, and to show the value of the standards program beyond reduced review times. The sample for the study was comprised of approximately 20% of ODE (Office of Device Evaluation) and OIVD (Office of In Vitro and Diagnostic Device Evaluation and Safety) pre-market review staff. The survey consisted of 16 questions designed to capture the opinions of each reviewer on the value of standards.The results indicated that100% of those surveyed were either satisfied or very satisfied with the program.A majority of those surveyed felt there was a need for greater training. Over all there was satisfaction with the program in helping with the pre-market review process.
Guidances: OSEL issued four guidances in 2007. Mr. Donald Witters, Jr. , Division of Physics, led a team that drafted Draft Guidance for Industry and FDA Staff - Radio-Frequency Wireless Technology in Medical Devices. Ms. Herman led a team that revised three standards guidances: (1) Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards, (2) Guidance for Industry and FDA Staff - CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition, and (3) Guidance for Industry and FDA Staff - Frequently Asked Questions on Recognition of Consensus Standards.
Global Harmonization Task Force (GHTF). GHTF is an international voluntary group of representatives from national medical device regulatory authorities and the regulated industry. The United States is one of the five founding members of GHTF. Members are from the following three geographical areas: Asia, Europe, and North America.
The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness, performance and quality of medical devices; and promoting technological innovation and facilitating international trade. The primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices. The study groups are responsible for the drafting of the harmonized guidance documents.
The Chairmanship of GHTF rotated to FDA after being held by the European Union for 3 years. FDA assumed the Chair of GHTF in late December 2006 and will hold the Chair for 18 months, until June 2008. FDA appointed Dr. Larry Kessler, Director of the CDRH Office of Science and Engineering Laboratories, to be the Chair and Ms. Jean Olson, Standards Management Staff, to the Secretariat.
In May 2007, Dr. Kessler chaired a 3-day steering committee meeting held in FDA’s District Office in Irvine, California. A joint GHTF study group meeting was also held concurrently with the steering committee meeting, both on that site. Approximately 35 people attended the steering committee meeting, and approximately 90 people attended either the steering committee or joint study group meetings.
In October 2007, Dr. Kessler chaired a second steering committee meeting held in Washington, D.C. (for 3 days) in conjunction with the (2-day) GHTF Conference. Approximately 300 persons attended the Conference which included workshops on nanotechnology (Emergence of Nanotechnology and Its Impact on Device Regulatory Harmonization) led by OSEL Deputy Director Dr. Subhas Malghan (two sessions) and on software (Regulatory Considerations of Medical Device Software) led by Mr. Brian Fitzgerald. The conference was followed by 2 days of training on GHTF documents. Ms. Olson worked with a team from FDA and AdvaMed to coordinate the logistics of the steering committee meeting and the conference.
Dr. Kessler and Mr. Fitzgerald worked on the ad hoc software group. As a result, the Software ad hoc group was formed, headed by Mr. Fitzgerald, and the group forwarded work items to the GHTF Steering Committee for approval in November 2006. The software ad hoc group continues its work under Mr. Fitzgerald's leadership. Dr. Kessler also leads the ad hoc group working on GHTF Training and the ad hoc group exploring developing GHTF’s relationship with the World Health Organization (WHO). FDA/CDRH continues to manage the GHTF website.