Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting
Published: 2011-12-20T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Medical devices can significantly improve, and save, the lives of children. Yet according to the Department of Health and Human Services (HHS) Food and Drug Administration (FDA), the development of pediatric devices lags years behind the development of devices for adults. The FDA Amendments Act of 2007 (FDAAA) provided incentives to develop devices for children, particularly devices that receive FDAs humanitarian device exemption (HDE), a process for devices that treat or diagnose rare diseases or conditions. FDAAA also authorized demonstration grants for nonprofit consortia to facilitate pediatric device development and required FDA to annually report the number of approved devices labeled for use in pediatric patients. Finally, FDAAA required GAO to report on pediatric device development. This report (1) describes barriers to developing pediatric devices, (2) describes how pediatric device consortia have contributed to the development of pediatric devices, and (3) examines FDA data on the number of pediatric devices approved since FDAAA was enacted. GAO examined FDA data and documents related to device approvals, reviewed relevant laws and regulations, and interviewed and reviewed documents from stakeholders and FDA officials.
section_title: What GAO Found
paragraphs: Certain characteristics unique to pediatric populationsincluding physiological differences from adult patients and challenges with recruiting pediatric participants for clinical trialsare barriers to developing medical devices for pediatric use cited by stakeholders. Given the unique characteristics of the pediatric population, and because the market for pediatric devices is smaller than the market for adult devices, there are limited economic incentives for manufacturers to develop pediatric medical devices.
FDAAA provisions authorized demonstration grants for pediatric device consortiathese consortia reported assisting over 100 pediatric device projects in the first 2 years of the program, fiscal years 2009 and 2010. FDA awarded grants totaling about $5 million to four pediatric device consortia in these 2 years. Of the device projects assisted by the consortia, many projects were in early stages of development, such as the creation of a prototype and the preclinical testing of that prototype. Activities performed by the consortia included regularly scheduled forums where innovators could discuss new device ideas with a group of experts.
FDA lacks reliable internal data with which to identify all pediatric devices. FDAAA required FDA to annually report to congressional committees on the number of devices approved in the preceding year that were labeled for use in pediatric patients. While FDA created an electronic flag in its internal tracking system to identify such devices, FDA has not consistently used this flag and therefore lacks reliable and timely information needed for reporting. GAOs review of the indication for use statements of devices approved since FDAAA was enacted identified 18 devicesincluding 3 HDE devices and 15 premarket approval (PMA) devicesthat were explicitly indicated for use in pediatric patients (patients age 21 or younger). However, the approved indication for use statements for most (72 percent) of the devices approved through the HDE or PMA processes did not specify the age of the intended patient population, so additional pediatric devices could exist.
section_title: What GAO Recommends
paragraphs: GAO recommends that FDA collect reliable information to report data on pediatric medical devices by consistently using its existing pediatric electronic flag in its tracking system or otherwise developing internal controls. HHS concurred with GAOs recommendations.

section_title: Letter
paragraphs: Medical devices prevent premature death and significantly improve the  quality of life for many children each year. However, stakeholders from  the pediatric community have raised concerns about the availability of  devices developed and approved for pediatric use. In particular, concerns  have been raised about challenges to developing and marketing pediatric  medical devices. Designing and developing pediatric medical devices can  be challenging because children’s bodies are often smaller, are structured  differently than adults, and change throughout childhood. According to the  Food and Drug Administration (FDA), in 2011 the development of medical  devices for children lagged 5 to 10 years behind the development of  devices for adults. Some medical devices are designed specifically for  pediatric patients and some are designed for patients above a certain  age. Frequently, providers modify devices designed for adults for use in  their pediatric patients.
FDA, an agency within the Department of Health and Human Services  (HHS), is responsible for ensuring that medical devices, including  pediatric medical devices, sold in the United States provide reasonable  assurance of safety and effectiveness and do not pose a threat to public  health. Before medical devices may be legally marketed in the United  States, they are generally subject to FDA premarket review unless  exempt by FDA regulations. Under FDA’s premarket approval (PMA)  process, manufacturers must supply evidence providing reasonable  assurance of safety and effectiveness to obtain FDA approval to market a  device in the United States; we refer to devices approved through this  process as PMA devices. To encourage development of devices that treat  or diagnose rare diseases or conditions, devices that receive a  humanitarian device exemption (HDE) are exempt from the effectiveness  requirement of the PMA process. Under FDA’s HDE process,  manufacturers are instead required to show that the probable benefit  outweighs the risk of using the device. In general, manufacturers of  devices approved through the HDE process are allowed to recover  certain development and production costs but may not make a profit on  their device; we refer to devices approved through this process as HDE  devices.
To encourage the development of pediatric medical devices, the FDA  Amendments Act of 2007 (FDAAA) removed the profit prohibition for HDE  devices that are used to treat children and meet other requirements,  and  established a demonstration grant program for nonprofit consortia to  stimulate pediatric medical device development.consortia receiving these grants, administered by FDA, are expected to  facilitate the development, production, and distribution of pediatric  medical devices through activities such as connecting innovators and  physicians to existing federal resources, assessing the scientific merit of  proposed pediatric device projects, and providing assistance and advice  as needed on business development. In addition, FDAAA required FDA to  annually report to the Senate Committee on Health, Education, Labor,  and Pensions and the House Committee on Energy and Commerce on   Pediatric device  pediatric medical devices, including the number of devices approved in  the preceding year that were labeled for use in pediatric patients.
FDAAA also required GAO to report on pediatric medical device  development. pediatric medical devices, (2) describe how the demonstration grants for  pediatric device consortia have contributed to the development of  pediatric medical devices, and (3) examine FDA’s data on the number of  pediatric PMA and HDE devices approved since FDAAA was enacted.
In this report, we (1) describe barriers to developing  To describe the barriers to developing pediatric medical devices, we  interviewed officials and reviewed documents from key pediatric medical  device stakeholders, including the pediatric device consortia;  manufacturer organizations, including the Medical Device Manufacturers  Association and the Advanced Medical Technology Association;  professional associations, such as the American Academy of Pediatrics,  the Pediatric Orthopaedic Society of North America, and the American  Thoracic Society; advocacy organizations, such as the Elizabeth Glaser  Pediatric AIDS Foundation and the National Organization for Rare  Disorders; and the two manufacturers of HDE devices approved for use in  pediatric patients and exempted from the HDE profit prohibition. In  addition, we interviewed officials from FDA and the National Institutes of  Health who conduct work related to medical devices. We also conducted  a literature review of government and independent reports and peer- reviewed publications and reviewed stakeholder testimonies and  summaries regarding barriers to pediatric medical device development. In addition, we examined policy papers written by key stakeholders,  including FDA and professional associations.
Pub. L. No. 110-85, § 303(b), 121 Stat. 823, 862 (2007).
To describe the contributions of the pediatric device consortia, we  reviewed pediatric device consortia quarterly and annual reports  submitted to FDA to assess the type and amount of assistance the  consortia provided to device innovators and manufacturers described in  the reports. We also reviewed additional information provided by FDA  and interviewed officials from FDA and the consortia and other relevant  stakeholders.
FDAAA required that we focus our report on medical devices that were approved for the  U.S. market through the PMA and HDE processes. For additional information on devices  cleared through the 510(k) premarket review process, see GAO, Medical Devices: FDA  Should Take Steps to Ensure That High-Risk Device Types Are Approved through the  Most Stringent Premarket Review Process, GAO-09-190 (Washington, D.C.: Jan. 15,  2009), and the Related GAO Products section at the end of this report. systems. Based on our examination, we generally found the data that  FDA maintains on the number of approved PMA and HDE devices  labeled for use in pediatric patients not to be sufficiently reliable for our  purposes and, as a result, in order to identify pediatric devices, we  reviewed FDA documents—the approval order, approved labeling, and  summary of safety and effectiveness data—that FDA makes publicly  available for each approved PMA and HDE device. Each document  contains the approved indication for use statement, which specifies the  disease and population the device is intended to treat. However, the  indication for use statement may not explicitly state if a device can be  used in pediatric patients; in these cases, FDA may still consider the  device to be labeled for use in pediatric patients based on other  information in the labeling or summary documents. Given the extent of  information and expertise needed to determine if a device is labeled for  use in pediatric patients, for our analysis we considered pediatric devices  to be those explicitly indicated for use in pediatric patients when the  indication for use statement in these approval documents (1) specified a  population that included patients age 21 years or younger, (2) stated that  the device was for pediatric patients, or (3) stated that it was for skeletally  immature patients. We reviewed approval documents for PMA devices,  including PMA supplements called panel-track supplements, approved  in fiscal years 2006 through 2011 and HDE devices approved in fiscal  years 2001 through 2011.
In addition, to determine how many humanitarian use device (HUD)  designations—a required first step for FDA approval to market an HDE  device—FDA granted for devices used to treat diseases that occur in  pediatric populations since FDAAA was enacted, we analyzed data  provided by FDA for all HUD requests submitted and designated in fiscal  years 2001 through 2011. We interviewed FDA officials regarding  methods for tracking HUD requests and designations and determined that  the data were sufficiently reliable for our purposes. We also interviewed  FDA officials and reviewed FDA data to identify the HDE devices  exempted from the HDE profit prohibition and determined that these data  were sufficiently reliable for our purposes.
We conducted this performance audit from February 2011 through  December 2011 in accordance with generally accepted government  auditing standards. Those standards require that we plan and perform the  audit to obtain sufficient, appropriate evidence to provide a reasonable  basis for our findings and conclusions based on our audit objectives. We  believe that the evidence obtained provides a reasonable basis for our  findings and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: Medical devices include items used for the diagnosis, cure, mitigation,  treatment, or prevention of a disease. These devices range from simple  tools like bandages and surgical clamps to complicated devices like  pacemakers; unless exempt by FDA regulations, devices are generally  subject to FDA premarket review. Pediatric patients may be among those  a device is intended to treat and generally are defined as those age   21 years or younger. FDAAA included provisions to support and track  pediatric device development.
subsections: section_title: Medical Device Premarket Review Process
paragraphs: Unless exempt by regulation, medical devices are generally subject to  FDA premarket review before they may be legally marketed in the United  States. The extent of the premarket review is generally correlated with the  level of risk the device poses. Applications to market medical devices  are primarily submitted to and reviewed by FDA’s Center for Devices and  Radiological Health (CDRH).
Under the PMA premarket review process, FDA reviews and makes  approval decisions on applications for class III devices. Among other  things, PMA applications must include the indication for use—including  the disease and population the medical device is intended to treat—and  evidence (typically clinical data) providing reasonable assurance that the  device is safe and effective. After an initial screening of an application  and determination that the review should proceed, FDA’s reviewers  conduct a scientific review of the application and may refer applications to  an external advisory committee composed of individuals with expertise in  a particular medical specialty, such as cardiovascular or neurology— known as a medical specialty panel. FDA charges manufacturers a fee to  review PMA applications, but PMA applications for devices intended  solely for pediatric use are exempt from any fees.
For devices that have been approved through the PMA process, a  manufacturer that wants to add a pediatric population (or otherwise  significantly change the approved indication for use) must submit and  receive FDA approval for a PMA panel-track supplement. manufacturers a fee to review PMA panel-track supplements, but those  intended solely for pediatric use are exempt.
In 1990, Congress authorized FDA to exempt from the premarket review  requirement to demonstrate effectiveness certain medical devices in  order to provide an incentive for the development of devices that treat or  diagnose rare diseases or conditions, including those in children.  Manufacturers of such devices still must show that the probable benefit  outweighs the risk of using the device and that the device will not expose  patients to unreasonable or significant risk of illness or injury. These  devices, called HUDs, are intended to treat or diagnose a disease or  condition that affects fewer than 4,000 individuals in the United States. In  order to market an HUD in the United States, an HDE application must be  submitted to and approved by FDA.
Although FDA reviews and approves other types of PMA supplements, a panel-track  supplement is required if the manufacturer wants to change the indication for use of an  approved PMA device to add a pediatric population, according to FDA officials. must also provide a description of the device and scientific rationale  for the use of the device for the rare disease or condition.
Once the HUD designation is granted, the manufacturer can then  seek device approval by submitting an HDE application. In addition to  including the indication for use, the HDE application must include a  detailed description of the device, along with evidence demonstrating  device safety, and data and a rationale supporting the probable  benefit of the device. Device labeling is also reviewed and must  include a statement indicating that the device is a humanitarian  device. According to FDA guidance, criteria for HDE approval are  focused on safety, probable benefit, and lack of a comparable device.  FDA does not charge manufacturers a fee to review HDE  applications.
Manufacturers of HDE devices are allowed to recover certain  development and production costs but are generally prohibited from  making a profit on their device. Unless exempt, HDE applications must  include a cost assessment to demonstrate that the amount charged for  the HDE device does not exceed the cost of research and development,  fabrication, and distribution. After FDA approval, in order for an HDE  device to be used in patient care, it must be reviewed and approved by an  institutional review board (IRB) to assess the safety of the device.
If FDA review results in premarket approval, FDA issues an approval  order to the manufacturer, which includes the approved indication for use  statement. FDA also approves all printed material accompanying the  device—known as the device labeling. The approval order, labeling, and  a summary of safety and effectiveness data are available on FDA’s  website; all three documents contain the approved indication for use  statement.
section_title: Pediatric Populations for Medical Devices
paragraphs: Although the upper age limit experts use to define the pediatric population  varies, for purposes of certain statutory provisions for PMA and HDE  device applications, FDA considers pediatric patients as those who are  age 21 years or younger at the time of diagnosis or treatment. FDA  issued guidance in 2004 that specifies age ranges for four main pediatric  subpopulations: neonate, infant, child, and adolescent (see table 1).  According to FDA officials, the agency defined an additional  subpopulation, transitional adolescents, for its internal application review  purposes. These officials noted that in some cases patients in this age  range may not require special considerations compared to adults. A  pediatric medical device may be indicated for use in more than one  pediatric subpopulation.
According to FDA officials, some pediatric devices are indicated for use in  both pediatric and adult patients, such as devices with an indication for all  patients with a given condition above a certain age. Additionally, a  device’s indication for use statement might not specify the age of the  intended population, but based on additional clinical information that may  be included in the approval documents, FDA might consider a device  labeled for pediatric use. For example, the indication for use statement for  an influenza diagnostic test might not specify a pediatric population, but  FDA could consider the device labeled for patients of all ages. In addition,  a device’s indication for use statement might specify a minimum blood  vessel size or body weight rather than a certain patient age, and if  pediatric patients meet the criteria, the device could be considered  labeled for pediatric use.
section_title: FDAAA Provisions on Pediatric Medical Device Development
paragraphs: To stimulate pediatric medical device development, FDAAA exempted  HDE devices labeled for use in pediatric patients (including those for both  pediatric and adult patients) from the HDE profit prohibition for  applications approved on or after September 27, 2007, when FDAAA was  signed into law.prohibition, HDE applications must include data to prove that the device   In order to receive the exemption from the profit  can safely be used in a pediatric population and to support the number of  individuals likely to use the device each year. Based on this information,  FDA determines an upper limit on the number of devices that can be  distributed or sold each year—to treat both pediatric and adult patients— known as the annual distribution number (ADN). Manufacturers may only  receive profits from the sale of HDE devices exempt from the profit  prohibition and indicated for pediatric or pediatric and adult use up to the  ADN. In addition, FDAAA requires that FDA’s Pediatric Advisory  Committee annually review all HDE devices granted exemption from the  profit prohibition to ensure that the exemption remains appropriate for the  pediatric populations for which it is granted.
FDAAA also required PMA and HDE applications to include, if readily  available, a description of any pediatric population or subpopulation(s)  that suffer from the disease or condition that the device is intended to  treat, diagnose, or cure and the number of affected pediatric patients.  FDAAA further required FDA to annually report to congressional  committees on the number of PMA and HDE devices approved in the  preceding year (1) for which there is a pediatric subpopulation that suffers  from the disease or condition that the device is intended to treat,  diagnose, or cure; (2) labeled for use in pediatric patients; and (3) exempt from user fees because the device was intended solely for pediatric use.
To help connect individuals with ideas for pediatric medical devices with  experienced professionals to assist them through the medical device  development process, FDAAA also authorized demonstration grants for  pediatric device consortia to promote pediatric device development.  Pediatric device consortia receive 2-year grants, administered by FDA, to  conduct certain activities for device projects, such as mentoring and  managing the development process, assessing the scientific merit of a  proposed device, and providing assistance and advice as needed on  business development and navigating the regulatory process. In their  demonstration grant applications, consortia were not only required to  demonstrate their capability to develop pediatric devices—by having  members with medical and scientific expertise in device development and  relationships with manufacturers—but they were also required to identify  two to five device projects that the consortia would directly support under  the demonstration grant. Grantees must submit quarterly and annual  reports to FDA describing how they have used grant funds to support  innovation and the phase of development for the devices for which they  provided assistance. Phases of development include, for example,  concept, prototype (during which a model is developed), clinical (during  which the device is tested), and marketing (during which the device goes  through the regulatory process).
section_title: Characteristics of the Population and Limited Economic Incentives Cited as Barriers to Pediatric Device Development
paragraphs: Certain characteristics unique to pediatric populations—including  physiological differences in pediatric patients and challenges with  recruiting pediatric participants for clinical trials—are barriers to  developing pediatric medical devices that were cited by stakeholders.
Pediatric patients are composed of different subpopulations with  differences in size, growth rate, metabolism, heart rate, activity level,  and other differences. For example, younger pediatric patients— neonates, infants, and children—have higher heart rates or respiratory  rates than adults. This difference, as cited by some stakeholders,  makes some devices used for adults, such as certain heart valves, not  appropriate for use in young children; thus a device that has already  been developed for an adult may have to be redesigned for a pediatric  population. Another unique characteristic cited is the range of  pediatric subpopulations and the difficulty in developing potentially  different devices for each of these subpopulations. For example, a  device that is developed for a toddler may not be appropriate for use  in an adolescent, even if they have the same disease or condition. As  a result, manufacturers may have to develop and test a different  device for each subpopulation although the disease or condition may  be the same.
Recruiting pediatric patients to participate in clinical trials has also  been cited as a challenge for manufacturers. Performing experimental  procedures on children naturally raises concern for their safety, and it  may be difficult to obtain parental consent on behalf of the child to  conduct experimental procedures. This issue is compounded because  the pediatric population is not just one population but rather many  subpopulations. Therefore, manufacturers find it difficult to recruit  enough children for each pediatric subpopulation over a reasonable  time frame and within a manageable number of investigational sites to  ensure enough test subjects to meet clinical trial requirements.
Given these unique characteristics of the pediatric population, as well as  the fact that the market for pediatric devices is generally smaller than the  market for adult devices, there are limited economic incentives for  manufacturers to develop pediatric medical devices. Stakeholders  indicated that the cost of developing pediatric medical devices relative to  the potential revenue generated by sales in a small market is a significant  barrier to the development of new pediatric medical devices.  Stakeholders also noted that the cost of research and development for  pediatric medical devices can be the same as for adult devices while the  market size is often smaller. Given these factors, stakeholders report that  the return on the investment to develop and test pediatric medical devices  usually falls below the profit goals of most medical device manufacturers.
Stakeholders noted that the FDAAA provision allowing pediatric HDE  devices to earn a profit is one helpful step to encourage pediatric medical  device development; however, they indicated that this provision is not  enough to address the small market for pediatric devices and the  resources necessary to study a device in a pediatric population. An  official from one device manufacturer that had a pediatric HDE device  approved since FDAAA was enacted told us that the ability to earn a profit  for the HDE device, while helpful, was not part of this manufacturer’s  decision to develop and market it. Stakeholders noted that the maximum  number of 4,000 individuals for HDEs limited the effectiveness of this  incentive for development of devices for larger pediatric populations.  Stakeholders also noted that incentives used for pediatric drug  development would not necessarily work for pediatric medical device  development. For example, patent protection for medical devices is not as  meaningful an incentive as it is for the development of pediatric drugs  because the typical life cycle for medical devices (about 18 months) is  significantly shorter than the typical life cycle for a drug.
Other barriers identified by stakeholders included an incomplete  understanding of unmet pediatric device needs and issues related to the  medical device regulatory process.
Several stakeholders commented that there is no consistent inventory  of the devices that need to be developed for pediatric populations.  Although it is unclear who should maintain this inventory, FDAAA did  require FDA to annually report on the number of devices approved in  the preceding year that were labeled for use in pediatric patients or for  which there is a pediatric subpopulation that suffers from the disease  or condition that the device is intended to treat, diagnose, or cure.  FDA has reported to Congress that the pediatric device data  contained in these reports may help identify areas of pediatric device  research and development that need to be addressed. However,  FDA has issued only one of these reports to date. Furthermore,  some of the information from which FDA would develop these reports  may not be as useful as possible in determining unmet need.  Specifically, manufacturers are to include the information on pediatric  subpopulations in their premarket approval applications if readily  available; however, one manufacturer organization stated that it was  unclear about the specific information requirements, and thus  manufacturers may not be submitting useful information for tracking  unmet pediatric device needs.
Stakeholders also cited as barriers to pediatric device development  certain issues related to the medical device regulatory process in  general. For instance, it was reported that the amount of time that it  will take to get through the regulatory process cannot always be  predicted, which limits the ability to appropriately budget for  development. One manufacturer organization also noted that FDAAA  authorized FDA to consider published data from adult studies and  studies in different age groups when determining effectiveness for  pediatric device approvals; this manufacturer organization commented  that where appropriate, FDA should also use scientific evidence other  than randomized controlled studies, such as well-documented case  histories, to show probable benefit or demonstrate effectiveness.  Recognizing the need to discuss the ways scientific research data can  be used for pediatric medical device applications, FDA announced in  November 2011 that it would hold a public workshop to discuss the  use of scientific research data, including published scientific literature,  to support and establish pediatric indications for medical devices.
Stakeholders also noted barriers that were unique to HDE devices,  including pediatric HDE devices. One manufacturer organization stated  that FDA has provided no general guidance to manufacturers regarding  the type or level of evidence that must be developed to demonstrate that  an HDE device meets the probable benefit standard. According to the  organization, this lack of guidance ultimately hinders the use of the HDE  program as a pathway to market devices that treat or diagnose diseases  and conditions that affect fewer than 4,000 patients, including pediatric  patients. According to stakeholders, difficulties in obtaining insurance  coverage for HDE devices are also a barrier to development because  HDE devices are approved by demonstrating safety but not effectiveness.
Although the two manufacturers’ representatives we spoke with reported  experiencing frustration with the HDE approval process, they noted that  overall, their interaction with FDA reviewers was positive in that FDA  responded to their questions in a timely manner and provided specific  guidance where necessary.
Finally, stakeholders stated that individuals with innovative ideas for new  pediatric medical devices do not necessarily know what steps to take to  bring their ideas for pediatric medical devices to the market, and it would  be helpful to connect these individuals with manufacturers and to help  them navigate the device development and regulatory process.  Individuals with ideas for medical devices range from engineers to  clinicians, who often need to work together to develop and manufacture a  pediatric medical device. In addition, it is necessary to have funds to  sustain development and an understanding of how to navigate the  regulatory process. A commonly cited example of the challenges faced by  pediatric device innovators is the experience developing the titanium rib,  which took about 14 years to develop before it was approved for the  market in part because its inventor, a physician who saw the need for  such a device, did not have the information or resources to navigate the  development and regulatory process. FDA officials and other  stakeholders reported that the pediatric device consortia have helped to  address this barrier. In addition, FDA officials reported that other efforts  by FDA to organize early meetings before device manufacturers submit  applications to clarify required clinical information and meetings with  groups such as the pediatric orthopedic surgeons have also helped  device innovators navigate the device development and regulatory  process.
section_title: Pediatric Device Consortia Have Assisted over 100 Device Projects; Many Were in Early Development
paragraphs: The pediatric device consortia reported assisting 107 pediatric device  projects—that is, projects to develop new pediatric devices—in the first   2 years of the demonstration grant program. In order to facilitate the  development and approval of pediatric medical devices, FDA awarded  grants totaling about $5 million to four pediatric device consortia in fiscal  years 2009 and 2010 (see table 2). The consortia receiving these grants  provided assistance that included review of projects by clinical experts to  evaluate the devices’ usefulness in a clinical environment and help  connecting innovators with manufacturers as well as potential sources of  additional federal grant funding. The consortia also conducted other  activities to support pediatric medical device development and connect  individuals who have ideas for medical devices with information and  resources, such as lectures, forums, and relevant conferences.
For the device projects assisted by the consortia, the phase of  development varied. Although the consortia assisted a total of 107 device  projects, 34 were inactive or were device projects that the consortia were  no longer assisting at the time of our review. Of the 73 active device  projects, about half (36) were in the prototype phase (see table 3).
In  order to monitor the progress of the device projects the pediatric consortia  assisted, FDA requires each consortium to report on the development  phase of each device project—including the directly supported device  projects included in the grantees’ applications as well as other device  projects that received consortia assistance—on a quarterly and annual  basis. Throughout the grant period, device projects were presented to the  consortia and consortia members determined the kind of assistance to  provide for development of these devices. The assistance provided  depended on the device’s phase of development. For example, for a  device in the concept phase a consortium could assess its scientific merit  to see if there is a need for the device or if it makes sense to develop it;  for devices that were further along, a consortium could help produce  prototypes. For devices in the marketing phase, the consortia could  consult on next steps, including working with FDA, a step which the  developer needs to take to market a device. As of the most recent  grantee reports available in September 2011, 3 of the 107 devices that  were assisted by the consortia were commercially available and 1 had  received HUD designation.
Of the 107 device projects assisted by the consortia, 13 were directly  supported—that is, they were identified in the grant awards to receive a  portion of the grantee’s demonstration grant funding. Table 4 lists these  directly supported device projects, which were identified by the grantees  in their applications and selected by FDA to receive support through the  consortia grants. FDA’s evaluation criteria included (1) the significance of  the device to address pediatric needs, (2) how well the project was  designed, (3) the likelihood for marketing success, (4) the expertise and  training of project leaders, and (5) evidence that the institution where the  consortium was located supported the project.
section_title: FDA Lacks Reliable Information to Readily Identify All Pediatric PMA and HDE Devices
subsections: section_title: FDA Has Not Consistently Collected Reliable and Timely Information Needed to Report on Pediatric Devices
paragraphs: Although FDAAA required FDA to annually report to congressional  committees on the number of PMA and HDE devices approved in the  preceding year that were labeled for use in pediatric patients, the agency  lacks reliable information to readily identify all such pediatric devices.  Under standards for internal control in the federal government, relevant,  reliable, and timely information should be available for external reporting  purposes; however, FDA has not consistently collected reliable and timely  information needed to report on pediatric devices. In response to  FDAAA, FDA developed an electronic flag within its Center Tracking  System (CTS) in 2008, to help CDRH internally identify PMA and HDE  devices that were labeled for use in pediatric patients.officials, the agency’s medical device reviewers should check the  pediatric flags during the PMA and HDE process based on all of the  information available in the application. However, FDA officials reported  that these electronic flags are not consistently applied, and that the  agency does not provide formal training or guidance to its device  reviewers regarding proper implementation of the pediatric flags.  Therefore, information from FDA’s tracking system is not sufficiently  reliable to identify PMA and HDE devices labeled for use in pediatric  patients.
According to FDA  In the absence of reliable information from its internal tracking system that  could be retrieved in a timely manner to identify approved PMA and HDE  devices labeled for use in pediatric patients, FDA reported that staff  completed labor-intensive file reviews—which included examining  voluminous application files as well as discussion with FDA reviewers—to  complete its first annual report. This report, which covered devices  approved in fiscal year 2008, did not specify the criteria FDA used to  identify devices labeled for use in pediatric patients in its manual data  collection process. An FDA official involved in the preparation of the fiscal  year 2008 report told us that FDA staff considered devices to be labeled  for pediatric patients if FDA officials determined that the devices were for  patients younger than 18 years of age; however, this criterion was not  explicit in the report. Instead, FDA’s report noted that a committee report  described pediatric medical devices as those used to treat or diagnose   Further, in  diseases or conditions in patients from birth through age 21.the absence of documented criteria used to prepare the fiscal year 2008  report, FDA officials involved in preparing the combined fiscal years 2009- 2010 report at the time of our review were not aware of the specific  criteria used for the fiscal year 2008 report and, as a result, created their  own criteria and labor-intensive file review for identifying and reporting on  approved PMA and HDE devices labeled for use in pediatric patients. As  of October 2011, the combined fiscal years 2009-2010 report had not  been issued; FDA officials reported that it was in the agency’s internal  review and clearance process.
In addition, FDA does not have readily available, reliable information to  identify other pediatric information that FDAAA required the agency to  report annually. Specifically, FDA officials said that the agency does not  have reliable information to readily identify and report on the number of  PMA and HDE devices approved each year for which there is a pediatric  subpopulation that suffers from the disease or condition that the device is  intended to treat, diagnose, or cure.to annually report the number of PMA devices exempt from a user fee  because they were solely intended for pediatric use. Although the agency  reported that none of the devices approved in fiscal year 2008 were  exempt from a user fee for this reason, FDA officials stated that as a  result of our inquiry they reevaluated some of the PMA applications for  which user fees were paid and identified certain PMA applications from  other years that may not have properly received the user fee exemption.  FDA officials said they were in the process of providing refunds to  applicants that should have been exempt from the user fee.
Furthermore, FDAAA required FDA  Without readily available information on the approved PMA and HDE  devices labeled for use in pediatric patients or the number of approved  devices for which a pediatric subpopulation might be indicated, FDA  cannot easily identify and aggregate data to complete statutorily required  reporting in a consistent and timely manner. The inconsistent information  presented in these reports makes it more difficult for policymakers,  industry stakeholders, and innovators to identify what opportunities and  needs exist for devices to diagnose and treat pediatric patients.
section_title: Fifteen PMA and 3 HDE Devices Have Been Explicitly Indicated for Use in Pediatric Patients since FDAAA Was Enacted
paragraphs: While the indication for use statement for most approved PMA and HDE  devices did not identify the age of the intended population, our review  identified 18 devices approved since FDAAA was enacted that were  explicitly indicated for use in pediatric patients.found that 15 PMA and 3 HDE devices approved since FDAAA was  enacted have indication for use statements explicitly stating that the  devices are for patients that include patients age 21 or younger, pediatric  patients, or skeletally immature patients. However, the approved  indication for use statements for most of the 118 PMA and HDE devices  approved since FDAAA was enacted do not specify the age of the  intended patient population. Specifically, the indication for use statement   Specifically, our review  was silent on the age of the intended patient population for 75 percent of  PMA devices and 38 percent of HDE devices approved during that time  (see fig. 1). Given that a device’s indication for use statement may not  explicitly state the age of the intended patient population or specify if it is  for pediatric patients, additional pediatric devices could exist because  other labeling and clinical information can be used to determine if the  device can be used in pediatric patients.
Of the 18 PMA and HDE devices explicitly indicated for use in pediatric  patients since FDAAA was enacted, most were explicitly indicated for  adolescents. The majority of those indicated for adolescents were  indicated for patients age 18 and older. Nine devices (50 percent) were  indicated solely for patients age 18 or older—the age group FDA  considers to be transitional adolescents for internal application review  purposes—and 2 of those were indicated solely for patients age 21 or  older. Two devices were explicitly indicated for children and none were  explicitly indicated for neonates or infants (see table 5). In addition, the  most common medical specialties of devices explicitly indicated for use in  pediatric patients were microbiology (39 percent); cardiovascular   (22 percent); anesthesiology and ear, nose, and throat (11 percent each);  and clinical chemistry, ophthalmology, and gastroenterology (6 percent  each).
Although three HDE devices approved since FDAAA was enacted were  explicitly indicated for use in pediatric patients, the number per year may  increase in the future, as the number of HUD requests and designations  per year for devices intended to treat diseases that occur in pediatric  patients increased after FDAAA was enacted. Because HUD  designation is the first step to obtaining HDE approval, increasing HUD  designations indicate potential for future pediatric HDE devices.According to FDA, the agency received about one HUD request per year  on average for devices intended to treat a disease that occurs in pediatric  patients before FDAAA was enacted and about five requests per year on  average in the years after the law was enacted. Likewise, FDA granted  about one HUD designation for devices intended to treat a disease that  occurs in pediatric patients per year prior to FDAAA and almost five such  HUD designations per year in the years after (see fig. 2).
Since FDAAA was enacted, two of the three HDE devices explicitly  indicated for use in pediatric patients (patients age 21 years or younger)  were granted the exemption from the HDE profit prohibition. One of  these two exempted devices, the Medtronic Melody® Transcatheter  Pulmonary Valve and Ensemble® Transcatheter Valve Delivery System  (Melody® TPV) was approved in January 2010 for use in treating  pediatric and adult patients with a blocked or leaky pulmonary heart valve  that has previously been replaced to correct congenital (birth) heart  defects and with a vessel size above a certain threshold. In September  2011, FDA’s Pediatric Advisory Committee reviewed the Melody TPV and  determined that the HDE profit prohibition exemption remained  appropriate.Anastamosis) Surgical KitHUD was approved in March 2011 for use in  neurosurgery during intracranial vascular bypass procedures in patients  13 years of age or older who meet certain criteria. (See app. I for more  information on the two devices.)
section_title: Conclusions
paragraphs: It is too early to determine if the FDAAA provisions authorizing  demonstration grants for pediatric device consortia or allowing  manufacturers to earn a profit on pediatric HDE devices have had a  substantial impact on the number of approved pediatric devices; however,  the provisions show potential for more pediatric devices in future years.  Although stakeholders identified barriers to developing and receiving FDA  approval to market pediatric medical devices, programs such as the  pediatric device consortia can foster an environment for device innovators  to share ideas and advance the development of pediatric medical  devices. The number of devices that the pediatric device consortia have  supported through the early phases of development and the positive  feedback from stakeholders indicate that pediatric devices are being  developed. Further, the increase in the number of HUD requests and  designations for devices that treat pediatric populations since FDAAA was  enacted indicate potential for development of additional pediatric HDE  devices in the near future. Over the past 10 years, it has taken a few  years for a manufacturer to submit an HDE application and receive FDA  market approval after receiving HUD designation; therefore the profit  eligibility incentive for pediatric HDE devices may have induced an  increase in the number of pediatric HUD requests.
Although the future for pediatric device development may be promising,  FDA lacks reliable and timely information on pediatric devices approved  for the U.S. market. To meet statutory reporting requirements, FDA must  have data systems in place to produce timely, reliable information to  readily identify and track devices the agency has approved for use in  pediatric patients. Without a systematic database to identify medical  devices approved for use in pediatric patients, FDA cannot provide data  so that policymakers, innovators, and physicians may understand the  extent of medical device availability and needs for further development.
section_title: Recommendation for Executive Action
paragraphs: We recommend that the Commissioner of FDA collect reliable information  to report data related to pediatric medical devices. Specifically, FDA  should take steps to consistently collect information using its existing  pediatric electronic flag or otherwise develop internal controls to readily  and reliably collect and report information on devices for pediatric use.
section_title: Agency Comments
paragraphs: We received comments on a draft of this report from HHS, which are  reproduced in appendix IV. The department agreed with our  recommendation that FDA collect reliable information related to pediatric  medical devices and commented that FDA is in the process of modifying  and updating its current tracking system, related data quality controls, and  training program requirements for pediatric medical device premarket  submissions. The department further stated that when this process is  complete, FDA’s pediatric information collection efforts will satisfy the  department’s pediatric device operations and oversight needs, including  the development of the annual pediatric report.
We are sending copies of this report to the Secretary of Health and  Human Services, the Commissioner of FDA, and other interested parties.  In addition, the report will be available at no charge on the GAO website  at http://www.gao.gov.
If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or crossem@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made major contributions to  this report are listed in appendix V.
section_title: Appendix I: Summary of HDE Devices Granted Exemption from the HDE Profit Prohibition
paragraphs: The Food and Drug Administration Amendments Act of 2007 (FDAAA)  also required that we describe the key characteristics of devices  approved through the humanitarian device exemption (HDE) process that  were granted exemptions from the HDE profit prohibition because they  were labeled for use in pediatric patients. This appendix describes the  conditions and the indicated patient populations of the two pediatric  medical devices that were granted exemption from the HDE profit  prohibition—Medtronic Melody® Transcatheter Pulmonary Valve and  Ensemble® Transcatheter Valve Delivery System (Melody® TPV) and  ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical  KitHUD. We also describe when each device was approved for the U.S.  market and what is known about profits made by the manufacturers of  each device. In addition, we describe what is known about the costs and  insurance coverage and off-label use of the Melody TPV device—the one  HDE device exempt from the HDE profit prohibition that was sold and in  use in the United States at the time of our review.
subsections: section_title: Summary of Pediatric HDE Devices Exempt from the HDE Profit Prohibition
paragraphs: To describe the key characteristics of each device, we interviewed  officials from Medtronic, Inc., and Elana, Inc.—manufacturers of the  Melody TPV and ELANA devices, respectively—and examined  manufacturer-provided documentation, such as billing code information,  related to the Melody TPV device. We also interviewed officials from the  Food and Drug Administration (FDA) who manage the HDE process and  examined FDA documents for each device, including approval documents  and an annual report for the Melody TPV—which manufacturers granted  exemption from the HDE profit prohibition are required to submit annually  to FDA. (Table 6 provides key characteristics of the two pediatric HDE  devices granted exemption from the HDE profit prohibition.)
section_title: Survey of Physicians and Hospitals That Have Used the Melody TPV
paragraphs: To obtain information regarding costs of the Melody TPV device as well  as insurance coverage for and off-label use of the device, we surveyed 36  physicians at the 25 children’s hospitals and pediatric units of medical  centers (which we collectively refer to as children’s hospitals) that  according to the device’s manufacturer, had used the Melody TPV at  least 10 times. We received complete responses from 27 physicians at  20 children’s hospitals for an overall response rate of 75 percent of  physicians and 80 percent of hospitals in our sample.
Almost all (93 percent) of the 27 respondents reported that their hospital  purchased the Melody TPV at the manufacturer’s list price of $30,500. All but 2 physicians reported that their hospital purchased the two  components—the valve and the delivery system—of the Melody TPV  device separately. A physician that we spoke with said his hospital kept  several valves and several of each size delivery system in stock and  purchased more as needed. Twenty-four of the 25 physicians at  children’s hospitals that purchased the components separately reported  paying the list price for each component—$24,000 for each Melody  Transcatheter Pulmonary Valve and $6,500 for each Ensemble  Transcatheter Valve Delivery System.
Many physicians we surveyed reported that they experienced at least  some difficulty obtaining health insurance coverage for the Melody TPV  device regardless of the type of insurance held by the patient (see   table 7). Twenty-five of the 27 responding physicians reported  experiencing difficulty obtaining coverage for patients with private health  insurance at least some of the time, with 3 of those physicians reporting  that it was always difficult. For Medicaid and Children’s Health Insurance  Program (CHIP) coverage, 4 physicians reported that the device was not  covered at all by this type of insurance. Additionally, 18 of the 22  responding physicians who reported receiving reimbursement for the  device through Medicaid or CHIP also reported difficulty obtaining that  coverage at least some of the time, with 4 of those reporting that it was  always difficult. Most responding physicians (19 of 27) reported not  treating any patients covered by Medicare, but 4 of those who did treat  patients with Medicare coverage said that obtaining Medicare coverage   Further, 7 of the 27 responding  for the device was always difficult.physicians reported that health insurance coverage influenced their  clinical decision to use the device. For example, 3 physicians reported  that delay or denial of insurance coverage for the Melody TPV device has  led them to conduct open heart surgery in patients for whom use of the  device would otherwise have allowed them to delay this more invasive  surgery.
Consistent with what stakeholders reported about challenges to obtaining  insurance coverage for HDE devices in general, physicians we surveyed  reported challenges obtaining health insurance coverage for the Melody  TPV device. These included comments about the time required to discuss  coverage with the insurers to obtain reimbursement, insurers’ lack of  familiarity with the medical device, challenges because insurers consider  the medical device experimental, and problems because the Melody TPV  procedure did not have a current procedural terminology (CPT) code at  the time of our survey.
About half (52 percent) of physician respondents reported that they have  implanted the Melody TPV device in a pediatric or adult patient for an  indication other than the indication on the label of the device—an off-label  indication—since it was approved for the U.S. market in February 2010.  However, all but 1 of those physicians said they used it off-label   20 percent of the time or less across instances when they implanted the  device in pediatric patients. Further, 29 percent of responding physicians  stated that they never used the device for an off-label indication in  pediatric patients. In addition, each instance of off-label use should have  been for an indication approved by the hospital’s institutional review  board (IRB). For example, 1 physician reported that he routinely  implanted the Melody TPV for one of three IRB-approved protocols, two  of which were for an off-label indication but all were for pediatric patients.
section_title: Appendix II: PMA and HDE Devices Explicitly Indicated for Use in Pediatric Patients since Fiscal Year 2006
paragraphs: Of the 118 devices approved through FDA’s premarket approval (PMA)  and HDE processes in the 4 years since FDAAA was enacted, 18   (15 percent) were explicitly indicated for use in only pediatric patients— those age 21 or younger—or both pediatric and adult patients. Of the   86 PMA and HDE devices approved in the 2 years before FDAAA was  enacted, 21 were explicitly indicated for use in only pediatric patients or  both pediatric and adult patients (see table 8). Of these, few devices were  explicitly indicated for use in patients under age 18—that is, in each fiscal  year, most devices that explicitly indicated a pediatric population were  indicated for use in patients age 18 years and older.
section_title: Appendix III: PMA and HDE Devices Explicitly Indicated for Use in Pediatric Patients, Fiscal Years 2008 through 2011
subsections: section_title: Device name, number Devices approved through the Food and Drug Administration’s (FDA) premarket approval (PMA) process Propel sinus implant, P100044
paragraphs: Pediatric  subpopulation   (if available)
Indicated for use in patients 18 years of age  or older following ethmoid sinus surgery to  reduce the need for postoperative  intervention.
Indicated for the in vitro qualitative detection  of antibodies to hepatitis B e antigen (anti- HBe) in human adult and pediatric (2 to 21  years old) serum from individuals who have  symptoms of chronic hepatitis and those  who have recovered from hepatitis B  infection.
Indicated for the treatment of fecal  incontinence in patients 18 years and   older who have failed conservative therapy  (e.g., diet, fiber therapy, and antimotility  medications).
Indicated for the in vitro qualitative detection  of hepatitis B e antigen (HBeAg) in human  adult and pediatric (2 to 21 years old)  serum from individuals who have symptoms  of hepatitis or who may be at risk for  hepatitis B virus infection.
Indicated to screen patients 21 years and  older with ASC-US (atypical squamous cells  of undetermined significance) cervical  cytology test results to determine the need  for referral to colposcopy or to assess the  presence or absence of high-risk Human  Papillomavirus genotypes 16 and 18, and  for other uses in women 30 years and older.
Indicated for the qualitative detection of  antibodies to hepatitis C virus in  venipuncture whole blood specimens from  individuals 15 years or older.
section_title: Date approved 4/27/2010
paragraphs: Summary of indication for use  Indicated for the treatment of severe  persistent asthma in patient 18 years and  older whose asthma is not well controlled  with inhaled corticosteroids and long-acting  beta agonists.
Indicated for patients with hearing loss who  meet the following criteria: (1) 18 years of  age or older, (2) stable bilateral  sensorineural hearing loss, (3) moderate to  severe sensorineural hearing loss defined  by Pure Tone Average, (4) unaided speech  discrimination test score greater than or  equal to 40 percent, (5) normally functioning  eustachian tube, (6) normal middle ear  anatomy, (7) normal tympanic membrane,  (8) adequate space for Esteem implant  determined via a high resolution  computerized tomography (CT) scan, and  (9) minimum 30 days of experience with  appropriately fit hearing aids.
Indicated for the qualitative detection of  antibodies to hepatitis B core antigen in  human adult and pediatric serum and  plasma and neonatal serum. It is intended  as an aid in the diagnosis of acute, chronic,  or resolved hepatitis B virus infection in  conjunction with other laboratory results  and clinical information. (No age provided,  indicated for  pediatric and adult  patients)
Indicated for reducing the severity of  postoperative cardiac adhesions in pediatric  patients who are likely to require  reoperation via sternotomy. (No age provided,  indicated for  pediatric patients)
Indicated for continually recording interstitial  fluid glucose levels in people ages 18 and  older with diabetes mellitus for the purpose  of improving diabetes management.
Indicated for the qualitative detection of IgM  antibodies to hepatitis B core antigen in  human adult and pediatric serum and  plasma and neonatal serum. It is intended  as an aid in the diagnosis of acute, chronic,  or resolved hepatitis B virus infection in  conjunction with other laboratory results  and clinical information. (No age provided,  indicated for  pediatric and adult  patients)
section_title: Device name, number PMA panel-track supplement devices Meditec MEL 80 Excimer Laser, P060004-S001
paragraphs: Pediatric  subpopulation   (if available)
Indicated for primary lasik treatments for   (1) the reduction or elimination of naturally  occurring hyperopia, (2) in patients who are  21 years of age or older, and (3) with  documentation of stable manifest refraction  over the past year.
A single-use immunoassay for the  qualitative detection of antibodies to  hepatitis C virus in fingerstick whole blood  specimens and venipuncture whole blood  specimens from individuals 15 years or  older.
Indicated for catheter-based cardiac  electrophysiological mapping (stimulating  and recording), for the treatment of (1) type  I atrial flutter in patients age 18 or older,   (2) recurrent drug/device refractory  sustained monomorphic ventricular  tachycardia due to prior myocardial  infarction in adults, and (3) drug refractory  recurrent symptomatic paroxysmal atrial  fibrillation.
section_title: Devices approved through FDA’s humanitarian device exemption process (HDE) ELANA Surgical KitHUD, H080005
paragraphs: Indicated for creating arteriotomies during  an intracranial vascular bypass procedure  in patients 13 years of age or older with an  aneurysm or a skull base tumor affecting a  large (> 2.5 mm), intracranial artery that  failed balloon test occlusion, cannot be  sacrificed, or cannot be treated with  conventional means due to local anatomy  or complexity.
Indicated for use as an adjunct to surgery in  the management of pediatric and adult  patients with the following clinical  conditions: Existence of a full  (circumferential) Right Ventricular Outflow  Tract (RVOT) conduit that was equal to or  greater than 16 mm in diameter when  originally implanted and Dysfunctional  RVOT conduits with a clinical indication for  intervention, and either Regurgitation: ≥  moderate regurgitation, or Stenosis: mean  RVOT gradient ≥ 35 mmHg. (No age provided,  indicated for  pediatric and adult  patients)
section_title: Date Device name, number approved NeuRx RA/4, H070003 6/17/2008
paragraphs: Summary of indication for use  Indicated for use in patients with stable,  high spinal cord injuries with stimulatable  diaphragms, but who lack control of their  diaphragms. The device is indicated to  allow the patients to breathe without the  assistance of a mechanical ventilator for at  least 4 continuous hours a day. For use  only in patients 18 years of age or older.
We identified each device’s medical specialty based on data from FDA’s product code classification  database—which contains device names and product codes assigned based upon the medical device  product classification designated under 21 C.F.R. Parts 862-892. Although the database indicated a  medical specialty of cardiovascular for the ELANA Surgical KitHUD, FDA officials reported that upon  further review they determined that the product code assigned for the device is technically inaccurate.  To correct this technical inconsistency, FDA will issue a corrected product code for this product in the  near future. The corrected medical specialty for the device should be neurology, according to FDA  officials.
section_title: Appendix IV: Comments from the Department of Health and Human Services
section_title: Appendix V: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Kim Yamane, Assistant Director;  Rebecca Abela; Carolyn Fitzgerald; Cathleen Hamann; Shirin Hormozi;  Lisa Motley; and Dan Ries made key contributions to this report.
section_title: Related GAO Products
paragraphs: Medical Devices: FDA Should Enhance Its Oversight of Recalls.   GAO-11-468. Washington, D.C.: June 14, 2011.
Medical Devices: FDA’s Premarket Review and Postmarket Safety  Efforts. GAO-11-556T. Washington, D.C.: April 13, 2011.
High-Risk Series: An Update. GAO-11-278. Washington, D.C.: February  2011.
Food and Drug Administration: Overseas Offices Have Taken Steps to  Help Ensure Import Safety, but More Long-Term Planning Is Needed.  GAO-10-960. Washington, D.C.: September 30, 2010.
Food and Drug Administration: Opportunities Exist to Better Address  Management Challenges. GAO-10-279. Washington, D.C.: February 19,  2010.
Food and Drug Administration: FDA Faces Challenges Meeting Its  Growing Medical Product Responsibilities and Should Develop Complete  Estimates of Its Resource Needs. GAO-09-581. Washington, D.C.:   June 19, 2009.
Medical Devices: Shortcomings in FDA’s Premarket Review, Postmarket  Surveillance, and Inspections of Device Manufacturing Establishments.  GAO-09-370T. Washington, D.C.: June 18, 2009.
High-Risk Series: An Update. GAO-09-271. Washington, D.C.: January  2009.
Medical Devices: FDA Should Take Steps to Ensure That High-Risk  Device Types Are Approved through the Most Stringent Premarket  Review Process. GAO-09-190. Washington, D.C.: January 15, 2009.
Health-Care-Associated Infections in Hospitals: Number Associated with  Medical Devices Unknown, but Experts Report Provider Practices as a  Significant Factor. GAO-08-1091R. Washington, D.C.: September 26,  2008.
Medical Devices: FDA Faces Challenges in Conducting Inspections of  Foreign Manufacturing Establishments. GAO-08-780T. Washington, D.C.:  May 14, 2008.
Reprocessed Single-Use Medical Devices: FDA Oversight Has  Increased, and Available Information Does Not Indicate That Use  Presents an Elevated Health Risk. GAO-08-147. Washington, D.C.:  January 31, 2008.
Medical Devices: Challenges for FDA in Conducting Manufacturer  Inspections. GAO-08-428T. Washington, D.C.: January 29, 2008.
Medical Devices: FDA’s Approval of Four Temporomandibular Joint  Implants. GAO-07-996. Washington, D.C.: September 17, 2007.
Food and Drug Administration: Methodologies for Identifying and  Allocating Costs of Reviewing Medical Device Applications Are  Consistent with Federal Cost Accounting Standards, and Staffing Levels  for Reviews Have Generally Increased in Recent Years. GAO-07-882R.  Washington, D.C.: June 25, 2007.
Medical Devices: Status of FDA’s Program for Inspections by Accredited  Organizations. GAO-07-157. Washington, D.C.: January 5, 2007.