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FY 2005 ODE Annual Report - Part 2 - Reports from ODE Divisions

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In the following sections, each of the ODE review Divisions reports on some of their important accomplishments for FY05.


Diseases of global impact, such as Severe Acute Respiratory Syndrome (SARS), avian influenza, new strains of Clostridium difficile, and the first reported cases of monkeypox in the U.S. require constant vigilance. DAGID staff are frequently involved in efforts to prepare for the potential devastating effects of these diseases, whether they be naturally occurring or the result of bioterrorism. At the same time, the division has implemented new approaches to managing the premarket review process so that we may consistently meet the MDUFMA goals.

Communicating with the public 

DAGID staff are committed to providing the public with up-to-date, scientific information to be used to prepare for crises, such as pandemic flu. Our staff provided significant technical input into the content of CDRH’snew Personal Protective Equipment Website. This website, available at MedicalToolsandSupplies/PersonalProtectiveEquipment/default.htm, provides accurate, easy to understand information for general public and healthcare workers and describes devices that can be used during bioterrorism attacks, influenza pandemics, and other transmissible diseases as well as common questions and answers about personal protection.

Interacting with government agencies 

DAGID staff are also involved in many governmental Interagency Working Groups. We work closely with the Centers for Disease Control and Prevention and the Environmental Protection Agency. Our staff collaborate with our sister public health agencies on issues such as disinfection and sterilization, disease outbreaks, and other emerging public health problems. Some of the topics recently addressed related to Transmissible Spongiform Encephalitis (TSE), appropriate application of disinfectants for device decontamination, and clearance by EPA of surface disinfectants having a TSE claim. We participate in CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC). One of the primary functions of the committee is to issue recommendations for preventing and controlling health care associated infections. DAGID representatives have been instrumental in providing key information regarding regulations regarding medical devices especially those specifically intended to interrupt disease transmission such as sterilants and high level disinfectants and personal protective equipment.

Maintaining product safety throughout the product life cycle 

Through out the past year, DAGID has been involved in a number of important postmarket issues, including recalls of hospital beds, infusion pumps, and catheters. Our experts provided scientific and clinical advice regarding the root causes of these device problems and appropriate corrective actions.


Cardiovascular disease continues to be a significant problem for the public health, with cardiovascular devices serving an increasingly important role in the treatment of cardiovascular disease. As a result of this trend, the Division of Cardiovascular Devices (DCD) has become more involved in the development of appropriate technology than ever before. To meet these challenges and the challenge of meeting the MDUFMA goals, we have hired additional staff and streamlined our management of the premarket review process.

Analyzing trends in pacemakers and ICDs 

DCD was interested in analyzing trends in deaths and malfunctions for pacemakers and implantable cardioverter defibrillators (ICDs). We contracted with William Maisel ( Cardiovascular Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA) to review and analyze PMA annual reports for all pacemakers and ICDs between 1990 and 2002. The study showed that pacemakers and ICDs are generally safe and effective devices, and pointed out that the number of pacemaker and ICD implants has increased substantially. The study also contains two findings that are a source of concern to the FDA: first, the malfunction replacement rate for ICDs is significantly higher than the malfunction replacement rate for pacemakers, and, of perhaps greater concern, is that the ICD malfunction replacement rate appears to be increasing. The study concluded that careful monitoring of the device performance is still required, that the clinical community must continue to report adverse events in a timely manner, and that strategies should be developed to increase the proportion of explanted devices that are returned for manufacturer analysis.

Work with Heart Rhythm Society

Following a series of implantable defibrillator recalls between May and July of 2005, the FDA co-sponsored a policy conference with the Heart Rhythm Society on September 16, 2005, to bring together stakeholders from the clinical community, industry, patients, and regulators. Discussion focused on the current processes and practices for ensuring reliable products, conducting recalls, and notifying the public of problems. Areas of improvement were identified, and all groups agreed to work together to formulate solutions and create awareness of the issues. In response to these recalls, the FDA created an internal Defibrillator Working Group. This group is tasked with creating a Total Product Life Cycle (TPLC) model for the regulation of defibrillators. Along with creating a forum for sharing information across Offices, the group is developing guidance documents and operating procedures to facilitate cross-Office decision making, and effective external communication.

Modeling Cardiac Stent Performance 

FDA is providing scientific and regulatory expertise to Stanford Biodesign research aimed at developing simulation models and evaluative imaging technologies to predict cardiovascular and peripheral vascular stent performance.  FDA’s role is to guide this research so that it results in useful evaluative tool development, and to facilitate the development of ASTM Standards using the information gained from this research.  The critical path tools developed from this research could be used to rapidly and inexpensively assess the safety and efficacy of multiple alternative device designs prior to fabrication, physical testing, animal testing and human trials.  By the end of 2006, the research team expects to have completed an in vitro model of a Superfiscial Femoral Artery stent in motion, and imaging of pediatric patients with aortic coarctation.

Surrogate Variables Working Group

To stimulate development along the critical path of innovation, the FDA formed the Surrogate Variables Working Group in November 2004, with a collaborative group of individuals including FDA staff, academic statisticians and clinicians. Interest in clinical trials of new drug-eluting stents, a breakthrough technology that has had a substantial impact on patient care, was the initial impetus for the formation of this group and led to DCD’s involvement. The goal of the working group is to identify potential uses of surrogate variables in device development, specifically the use of surrogate variables as endpoints for clinical trials intended for regulatory submissions. The mission of the working group will be accomplished by achieving the following three tasks: 1) development of definitions and classifications for surrogate variables; 2) characterization of investigative “tools” to assess the utility of surrogate variables; and 3) identification of appropriate uses of surrogate variables in device clinical trials.

While drug-eluting stent clinical trials may serve as an initial example, the Working Group’s aim is to understand the appropriate role of surrogate variables in clinical trials across the field of medical devices. Dissemination of the working Group’s efforts will be achieved by submission of manuscripts for publication in peer reviewed journals, and presentation of issues discussed in the Surrogate Variables Working Group in a public forum. Multiple DCD personnel are actively working with other FDA staff, academics, and AdvaMed to accomplish these goals.


The Division of General Restorative and Neurological Devices (DGRND) reviews a wide variety of medical devices, including orthopedic implants, general and plastic surgery devices, physical medical and rehabilitation devices, and therapeutic and diagnostic neurological devices. Our staff have risen to the challenge of maintaining high scientific standards while at the same time, meeting all of the MDUFMA review time goals.

Leveraging with outside groups 

DGRND continues to work closely with industry, academic, clinical and other external groups such as the Orthopaedic Device Forum, the American Academy of Orthopaedic Surgeons, the Orthopaedic Surgical Manufacturer's Association, the Tissue Group, and the Society for Interventional Radiology. For example, our staff have a long-standing collaborative effort with the Orthopaedic Device Forum. The Forum was established to foster an environment of open communication among representatives of the scientific and clinical orthopaedic community, the FDA and other governmental agencies, and representatives of the industry related to musculoskeletal health and diseases. Regularly scheduled meetings of the Orthopaedic Device Forum provide valuable input to DGRND on a variety of topics including clinical trial development, guidance priorities, and voluntary standards.

Expanding our scientific knowledge base

DGRND staff continually seek opportunities to expand our scientific and clinical knowledge, which greatly enhances our review of innovative technologies. One example is the CDRH Neurologic Devices Interest Group, founded in 2003.  The objective of the group is to organize, facilitate, and share education and training opportunities and experiences related to neurologic device products as a means of enhancing and accelerating product review. Each meeting involves staff from across the agency, other government organizations, senior level academic researchers, and clinicians in the biomedical sciences to discuss emerging scientific and medical theory and clinical practice in an informal seminar setting.  Outcomes of the Neurologic Devices Interest Group have led to intra- and inter-Center communication and an organized review approach of medical products targeting neurologic disorders and conditions.

Meeting MDUFMA goals 

Over the past fiscal year, the DGRND united as a division to meet all MDUFMA goals.

We remain committed to developing guidance documents and reclassifications in all areas of the division to allow for efficient, timely and least burdensome review of all submissions.


DOED faced one of its most challenging and exciting years in 2005. The dedicated professionals of our staff assured that the primary mission of our division was achieved and our goals for the year were successfully implemented. Chief among them was the successful implementation of MDUFMA goals and milestones in our premarket review process. Our division personnel take great pride in the timeliness of our decisions and their grounding in sound scientific and regulatory principles. In 2006, we will continue to find ways to improve our review process and to assure timely decisions are reached without compromising public health and safety.

Outreach to the public and the clinical community 

In addition to its focus on meeting our application review times, DOED places a significant emphasis on outreach activities, scientific and regulatory collaborations, and on the development of national and international standards. For example, DOED staff spent a significant amount of time and resources in 2005 reaching out to our stakeholders through a variety of ways including scientific and regulatory publications in peer reviewed journals; writing educational columns in professional and consumer publications; teaching regulatory training courses, conducting seminars and making presentations at professional meetings; developing device specific guidance documents, and developing and updating ophthalmic and ENT device specific websites (e.g., LASIK, Cochlear Implants, Intraocular Lenses (IOLs)) for the general public. DOED believes that the exchange of knowledge and an improved understanding of the regulatory process by consumers, manufacturers, and health care professionals is a critical aspect of our public mission. We look forward to continuing and strengthening our commitment to outreach activities in 2006.

Building scientific knowledge through collaborative research 

In addition to our extensive outreach activities, DOED scientists participate in numerous collaborative studies with stakeholders to improve the premarket review process and to monitor the post approval performance of ophthalmic and ENT devices. DOED staff participate in many ongoing collaborative activities at various levels within the government and extend their collaborative efforts to organizations outside of government as well. Examples of ongoing premarket and postmarket collaborative efforts are described below.

Driving Simulation Studies 

Senior review scientists in DOED are involved in a collaborative study with researchers at the University of Iowa where the National Advanced Driving Simulator (NADS) is located and owned by The National Highway Traffic Safety Administration. The goal of this collaborative effort is to investigate possible correlations between driving performance measures with various ocular and visual tests and measures of the eye. Standard tests of vision used currently in clinical practice are not well correlated to a person's functional performance. The ultimate objective of the research is to find a surrogate for driving performance as a parameter of functional vision. If successful in our collaborative efforts, FDA review staff as well as ophthalmic device manufacturers will be able to correlate clinical outcomes to a person’s functional performance. It is hoped that the development and standardization of this methodology will improve and expedite the evaluation of safety and performance of new ophthalmic devices while reducing testing costs for manufacturers.

Pediatric Cochlear Implant Studies 

Senior review scientists in the Ear, Nose and Throat Branch ( ENTB) continue their collaboration with the Center of Disease Control (CDC) in a follow-up study on the cochlear implant pediatric cohort from the 2003 New England Journal of Medicine study. The study was published in the February 2006 issue of the journal Pediatrics (the study has been posted on the web via PubMed since January 3, 2006 ahead of the print version). The results of this study show that the children implanted with a cochlear implant with a positioner continue to be at increased risk for bacterial meningitis beyond 2 years post-implantation. These findings support the continued close monitoring of implanted patients and adherence to the safety precautions outlined by healthcare providers and parents/caretakers of children with cochlear implants, particularly among children with a positioner. It is still unknown whether the risk of meningitis in pediatric patients whose implants have positioners might be reduced if the implant were removed or replaced by a model that does not have the positioner. Any potential benefits of explantation surgery must be carefully weighed against the risks for operative complications, including perioperative meningitis. The present study concludes that there is currently insufficient information to support a recommendation for elective surgery to explant devices with a positioner.

International Club for Biomaterials and Regenerative Medicine in Ophthalmology 

DOED review scientists are active participants and have a leadership role in the International Club for Biomaterials and Regenerative Medicine in Ophthalmology (ICBRO). ICBRO was originally founded in Europe to promote interdisciplinary cooperative work by bringing together on an international level ophthalmic scientists, engineers and clinicians to advance the quality of existing devices by improving or creating new materials and test methods to assess those materials, and to develop new biocompatible, biodegradable materials useful for regenerative medicine in ophthalmology. The 2006 meeting will be the second meeting in the U.S. and will focus on advances in materials and testing for IOLs, contact lenses, glaucoma devices and retinal implants.


The Division of Reproductive, Abdominal and Radiological Devices has worked to meet our MDUFMA and non-MDUFMA deadlines as well as to maintain our involvement in other activities, e.g., guidance development, postmarket review, standards-setting, and professional development. The following are two important recent DRARD activities.

Pilot program to incorporate epidemiology expertise 

From February 2002 through December 2004, DRARD participated in an epidemiology pilot program with the Office of Surveillance and Biometrics (OSB). Twenty-eight of our staff worked with epidemiologists, safety analysts, and statisticians from OSB on first-of-a-kind PMAs to design postapproval studies. We developed standard operating procedures and epidemiology review templates; integrated epidemiologists into the premarket review team process; utilized available marketing data as analyzed by safety analysts; established new processes for capturing postmarket information; furthered the training of epidemiologists in premarket review procedures and presentations at Advisory Panel meetings; and developed evaluation instruments to assess the value added by the piloted processes. The success of the pilot in DRARD has led CDRH management to expand the program across all ODE divisions for first-of-a-kind PMAs.

Improving procedures for Industry meetings 

To assist firms in their interactions with us, DRARD has worked to improve the timeliness, efficiency, and productivity of our meetings. To accomplish these goals, the Division developed new meetings procedures. At the time of a meeting request, as a first step in the process, the Division asks for 10 copies of a meeting background package. Receipt of the background package will trigger the second step in the process, the prompt scheduling (usually within 45 days) of our internal pre-meeting and the meeting with the sponsor. We believe this two-step process enhances timeliness and efficiency for several reasons: first, the requestor will be able to prepare a background package on a time schedule that meets his/her needs; second, the Agency will have adequate time to review fully the background package and prepare for the formal meeting; third, good preparation on everyone’s part will enhance information exchange and productivity; and finally, the process should help to eliminate the need to re-schedule meetings due to incomplete preparation on the part of either party. Our project manager can provide additional suggestions on how to maintain open and effective communications between our Division and our stakeholders.

Outreach to scientific and clinical community 

The staff has remained actively involved in outreach to the scientific and clinical communities. Members of the Obstetrics and Gynecology Devices Branch (OGDB) have met with the American College of Obstetricians and Gynecologists (ACOG) clinical practice committees on device issues of interest including “keepsake videos,” fetal monitors, and condom labeling.   DRARD staff has also continued interactions with NIH researchers regarding technologies for detection and diagnosis of cervical disease.  We have established an ongoing series of conferences with NCI to discuss Pap tests and cervical screening.

Members of the Gastroenterology and Renal Devices Branch (GRDB) organized a meeting of the Gastroenterology and Urology Devices Advisory Panel on June 8, 2005, to discuss general issues related to the premarket requirements for the safe and effective use of hemodialysis equipment labeled for nocturnal home hemodialysis (NHHD) therapies. The panel members provided recommendations on monitors and alarms for the sleeping patient, quality of water at home, study design for small clinical trials, and training on how to use the device properly.

Page Last Updated: 03/06/2014
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