Food and Drug Administration: Data to Measure the Timeliness of Reviews of Medical Device Applications Are Limited
Published: 2004-08-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: FDA reviews applications from manufacturers that wish to market medical devices in the United States. To ensure prompt approval of new devices and clearance of devices that are substantially equivalent to those legally on the market, the Congress passed the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The act authorizes FDA to collect user fees and, in return, requires FDA to meet performance goals that are tied to the agency's review process. The goals set actions FDA may take on applications and specify the time that FDA should take in certain phases of the review process. MDUFMA requires GAO to report on FDA's performance against the MDUFMA performance goals established for fiscal years 2003 and 2004 and to determine whether FDA is likely to meet the fiscal year 2005 performance goals. MDUFMA also requires GAO to report on the amounts FDA obligated in fiscal year 2002 for medical device compliance activities and inspections of manufacturers after their devices are marketed. GAO analyzed data provided by FDA that are based on actions taken on applications FDA received from October 1, 2002, through March 31, 2004. GAO also analyzed data on the amounts FDA obligated for medical device compliance and inspection activities for fiscal year 2002.
section_title: What GAO Found
paragraphs: FDA had limited data that could be used to measure the agency's performance against most of the MDUFMA performance goals. Thus, it is uncertain whether FDA will meet the MDUFMA performance goals for fiscal years 2003, 2004, and 2005. For fiscal years 2003 and 2004, there were two performance goals in effect for each year. As of March 31, 2004, only one application was subject to the action tied to one of the two MDUFMA performance goals. On this application, FDA completed its review and made the decision to approve the application within the goal's established time frame. To determine the likelihood of meeting the 20 MDUFMA performance goals for fiscal year 2005, FDA is collecting data on its performance against these goals. GAO found that FDA had performance data for some, but not all, of the MDUFMA performance goals. From fiscal year 2003 applications, data were available to compare FDA's performance against 17 of the 20 fiscal year 2005 performance goals. FDA took actions tied to 14 of the 17 goals within the goals' established time frames. From fiscal year 2004 applications, data were available to compare FDA's performance against 11 of the 20 performance goals. FDA took actions tied to the 11 goals within the goals' established time frames. The results of FDA's performance against MDUFMA performance goals are preliminary, however, because 8 percent and 49 percent, respectively, of the applications FDA accepted in fiscal year 2003 and the first 6 months of fiscal year 2004 were awaiting action by FDA or responses from manufacturers. Because FDA's performance against the MDUFMA performance goals is based on the percentages of actions the agency takes within required review times, FDA's results could change as the agency completes its actions on all applications for which the goals apply. FDA obligated about $128 million for postmarket medical device compliance activities and inspections in fiscal year 2002. FDA obligated about $109 million for compliance activities for outreach coordination, such as guidance to field staff on reporting problems with medical devices, laboratory analyses, and research, such as the development of domestic and international standards to provide reasonable assurance that medical device products are safe and effective. FDA obligated about $19 million for inspections of device manufacturers' establishments, including routine surveillance inspections to determine compliance with medical device regulations and inspections resulting from device problem reporting or product recalls.

section_title: Letter
paragraphs: The Food and Drug Administration (FDA) is responsible for regulating  medical devices—such as tongue depressors, pacemakers, and artificial  hearts—to provide reasonable assurance of their safety and effectiveness  for human use. As part of its regulatory responsibilities, FDA reviews  applications from manufacturers that wish to have their new medical  devices or devices substantially equivalent to those already on the market  approved for marketing in the United States.  When required, FDA inspects  manufacturers’ establishments prior to approval. FDA is also responsible  for implementing and enforcing medical device regulations related to  compliance activities, which include the reporting of problems associated  with the safety and effectiveness of devices and inspections of  manufacturers’ device establishments after devices reach the market.
Each year FDA receives approximately 10,000 medical device applications.  Members of the Congress, representatives of the medical device industry,  and others have expressed concern about the length of time it takes FDA to  review applications for marketing medical devices, with the consequence  of possibly delaying patients’ access to useful, and possibly life-saving,  medical devices.
In October 2002, the Congress passed the Medical Device User Fee and  Modernization Act of 2002 (MDUFMA) to provide FDA with additional resources to ensure prompt approval or clearance of applications for  marketing medical devices and licensing biological products. MDUFMA  authorized FDA to collect user fees from manufacturers that submit several  types of applications to FDA for marketing medical devices. In return,  MDUFMA requires FDA to meet performance goals tied to the review  process for medical device and biological applications. MDUFMA also  requires the Secretary of Health and Human Services (HHS) to develop the  specific goals FDA must meet. The Secretary developed performance goals  for fiscal years 2003 through 2007. These MDUFMA performance goals are  set for certain actions FDA may take during the application review process  and specify lengths of time for taking these actions. FDA’s performance  against the MDUFMA performance goals is based on the percentages of  actions the agency takes on applications within required review times. To  help FDA meet the MDUFMA performance goals, the Secretary of HHS also  identified several goal-related activities for FDA to undertake, such as  hiring additional review staff.
The number of MDUFMA performance goals that FDA must meet increases  over time. For fiscal years 2003 and 2004, FDA must meet the same two  performance goals for each year. For example, one of the performance  goals requires FDA to review a manufacturer’s response to the agency’s  request for additional information on applications that are approvable with  minor corrections or clarifications, and then take the next appropriate  action, such as make a decision to approve the application. To meet the  performance goal, FDA must review and make the decision within 30 days  on 90 percent of the applications received for each fiscal year. In fiscal year  2005, FDA must meet the two goals and an additional 18 performance goals  tied to medical device and biological product applications, for a total of 20.   The 20 performance goals are tied to times for reviews, decisions, or a  combination of both.
MDUFMA requires us to report on FDA’s performance as measured against  the fiscal years 2003 and 2004 MDUFMA performance goals and determine  whether the agency is likely to meet the fiscal year 2005 MDUFMA  performance goals. MDUFMA also requires us to report on the amounts  FDA obligated in fiscal year 2002 for medical device compliance activities  and inspections of manufacturers’ device establishments after their devices  are marketed, excluding the amounts that were obligated for inspections  related to the review of medical device applications.
To examine FDA’s performance, we analyzed actions taken by FDA on  applications that it received from fiscal year 2003 through the first 6  months of fiscal year 2004 (October 1, 2003, through March 31, 2004).  At  the time of our review, performance data through March 31, 2004, were the  most current FDA data available. To assess FDA’s performance against the  two MDUFMA performance goals that were established for fiscal years  2003 and 2004, we analyzed performance data for applications received in  those years. To determine the likelihood of FDA meeting its fiscal year 2005  MDUFMA performance goals, we compared performance data that FDA is  collecting on fiscal years 2003 and 2004 applications to the 20 MDUFMA  performance goals that will be effective in fiscal year 2005. We also  reviewed relevant documents and interviewed officials from FDA’s Center  for Devices and Radiological Health (CDRH) and Center for Biologics  Evaluation and Research (CBER) about two key FDA medical device  application review processes and the agency’s performance as measured  against the MDUFMA performance goals. These two processes are referred  to as (1) the Premarket Approval (PMA) review process, which is used to  review an application for a new medical device or when the risks  associated with the device are considerable, and (2) the 510(k) review  process, which is used to review an application for a type of device that  may be substantially equivalent to one already on the market. In addition,  we reviewed documentation of FDA’s procedures for checking the  reliability of MDUFMA performance data and met with FDA officials to  discuss their efforts to verify the accuracy and consistency of their  reported performance data. We determined that the performance data were  sufficiently reliable for the purposes of this report.
To determine the amounts FDA obligated in fiscal year 2002 for medical  device compliance activities and inspections of manufacturers’ device  establishments after devices are marketed, we reviewed and analyzed data  from FDA’s fiscal year 2004 budget justification and information FDA  provided related to these data. The fiscal year 2004 budget justification  contains FDA’s fiscal year 2002 actual obligations for medical device  compliance activities and inspections. To assess the reliability of these  data, we reviewed supporting documentation that FDA provided on the  obligations reported in the agency’s fiscal year 2004 budget justification  related to compliance activities and inspections for marketed devices. We  also reviewed FDA’s fiscal year 2003 audited financial statement report that  contained information about the reliability of fiscal year 2002 obligations  data. The review found no material weaknesses related to our work. Based  on these reviews, we determined that the obligations data were sufficiently  reliable for the purposes of this report. We conducted our work from  January 2004 through August 2004 in accordance with generally accepted  government auditing standards.
subsections: section_title: Background
paragraphs: Under the Federal Food, Drug, and Cosmetic Act (FDCA), FDA is  responsible for ensuring that medical devices are reasonably safe and  effective before they go to market (premarket) and that marketed device  products remain safe (postmarket). Two FDA centers, CDRH and CBER,  are responsible for the PMA and clearance of medical device applications.  CDRH reviews applications for the majority of devices marketed, such as  artificial hearts, dialysis machines, and radiological devices. CBER reviews  applications for devices used in the testing and manufacture of biological  products, such as diagnostic tests intended to screen blood donors (such as  for the human immunodeficiency virus), as well as devices used in cell and  gene therapies.
Each fiscal year, FDA obligates funds for postmarket compliance activities  and inspections related to medical devices and radiological products. FDA  provides field staff with guidance on inspecting manufacturers’  establishments after devices have been marketed, for compliance with the  good manufacturing practices (GMP) requirements, monitoring  manufacturers’ corrections of problems with devices, and removing unsafe  devices from the market. FDA has 21 district offices that support  inspections of manufacturers’ establishments. During inspections for  compliance with GMP requirements, FDA investigators examine  manufacturer facilities, records of manufacturing processes, and corrective  action programs.
subsections: section_title: Types of Applications Reviewed under MDUFMA Performance Goals
paragraphs: MDUFMA identified eight types of applications for medical devices and  biological products that are subject to the performance goals developed by  the Secretary of HHS for fiscal years 2003, 2004, and 2005:  Original PMA applications are generally required when the device is new  or when the risks associated with the device are considerable (as would  be the case if the device is implanted in the body for life-supporting  purposes).
Premarket Notifications, or 510(k)s, are applications used when the  intent is to market a type of device that may be considered substantially  equivalent to one already on the market and therefore, does not require  PMA.
Premarket Reports are applications required for high-risk devices  originally approved for a single use that a manufacturer has reprocessed  for additional uses.
Panel-Track Supplements are applications used to supplement approved  PMAs or Premarket Reports. These supplements typically request  approval of a significant change in the design or performance of a  device, or for a new purpose for using the device.
Expedited Original PMAs are used when a manufacturer seeks priority  status to market a medical device that is intended to treat or diagnose a  life-threatening or irreversibly debilitating disease or condition or to  address an unmet medical need.
The 180-day PMA Supplements are used to supplement approved PMAs  or premarket reports. The application typically requests approval of a  significant change in aspects of a device, such as its design,  specifications, or labeling.
Biologics license applications (BLAs) Resubmissions (Class 1) are used  to respond to information requested by FDA on a BLA and may include  matters related to product labeling or safety and other minor clarifying  information.
BLA Supplement Resubmissions (Class 2) are used to respond to an  FDA request for information on a BLA regarding the safety and  effectiveness of products or a re-inspection of the manufacturer’s device  establishment.
section_title: FDA’s Medical Device Application Review Processes
paragraphs: FDA primarily uses two medical device application review processes; the  PMA review process and the 510(k) review process.  FDA annually  receives about 50 PMAs and about 4,000 510(k) applications for review  through these processes.
subsections: section_title: The PMA Review Process
paragraphs: Under the PMA review process, FDA reviews applications for new devices  or those for which risks associated with the device are considerable.  Applications reviewed under this process include Original PMAs,  Premarket Reports, Panel-Track Supplements, Expedited Original PMAs,  and 180-day PMA Supplements. After an initial screening of an application  and determination that the review should proceed, an FDA  multidisciplinary staff conducts a scientific review of the application and  determines whether it is complete, that is, if it contains sufficient  information to allow the review to continue. (See fig. 1.)
For complete applications, FDA may make one of five decisions. FDA may  (1) issue an order approving the application, which allows the  manufacturer to begin marketing the device; (2) send the manufacturer an  approvable letter pending a GMP inspection, which indicates that FDA  should be able to approve the device after the agency finds that the  manufacturer’s device establishment is in compliance with GMP  requirements; (3) send the manufacturer an approvable letter indicating  that the agency should be able to approve the device if the manufacturer  can make minor corrections or clarifications to the application; (4) issue a  “not approvable” letter informing the manufacturer that FDA does not  believe that the application can be approved because the data provided by  the manufacturer do not demonstrate that the device is reasonably safe and  effective; or (5) issue an order denying approval of the application, which  informs the manufacturer that the agency has completed its scientific  review, identified major safety and effectiveness problems, and decided not  to approve the application. FDA may refer complete applications to an  external advisory committee for evaluation when a device is the first of its  kind or when the agency believes it would be useful to have independent  expertise and technical assistance to properly evaluate the safety and  effectiveness of the device.  For applications referred to an advisory  committee, the committee submits recommendations to FDA on the safety  and effectiveness of the devices. Taking the committee’s recommendations  into consideration, FDA then makes its decision.
For incomplete applications, that is, applications for which FDA  determines it needs significant additional information, FDA issues a “major  deficiency letter” to the manufacturer identifying the information that is  required to provide reasonable assurance of the safety and effectiveness of  the device. This request for significant information is an action referred to  as a cycle action. In general, FDA takes cycle actions when it requests  additional information from the manufacturer, or when it evaluates  additional information provided by the manufacturer in response to an  FDA request. The manufacturer responds to FDA’s request by submitting an  amendment to the original application. Cycle actions on an application can  occur repeatedly until FDA determines that the manufacturer has provided  what the agency calls a “complete response” to all of the agency’s concerns.  Then, FDA may make a decision on the application.
Manufacturers that receive approvable letters pending minor corrections  or clarifications or not approvable letters can gain final approval by  submitting amendments with complete responses to FDA’s concerns. For  both types of decisions, if FDA, as part of a cycle action, determines that  the manufacturer’s amendment is a complete response, FDA issues an  order approving the application. If the amendment is not a complete  response, FDA issues another approvable letter pending minor corrections  or clarifications or a not approvable letter.
section_title: The 510(k) Review Process
paragraphs: Under the 510(k) review process, FDA decides whether the application  contains sufficient information to determine whether the device is  substantially equivalent to one legally on the market (see fig. 2). When a  510(k) application lacks information necessary for FDA to complete its  review and make a determination as to whether the device is substantially  equivalent, the agency issues a letter requesting additional information  from the manufacturer. This request for additional information is a cycle  action. The manufacturer may then submit additional information  responding to FDA’s concerns. Once FDA has obtained complete  information from the manufacturer, FDA issues a decision letter informing  the manufacturer that the device is substantially equivalent and therefore  may be marketed or the device is not substantially equivalent and may not  be marketed.
section_title: Measuring FDA’s Performance under MDUFMA
paragraphs: The MDUFMA performance goals specify a length of time for taking a cycle  action, making a decision, or a combination of both. The goals designate a  certain percentage of these actions that must occur within the specified  period in order for FDA to meet the performance goals. To measure its  performance against the MDUFMA performance goals, FDA tracks the  time, in calendar days, the agency takes to complete a cycle action or make  a decision—but not the time it takes a manufacturer to respond to a  request from FDA.
FDA measures its performance against a specific fiscal year’s MDUFMA  performance goals using all the applications it received in that year— known as a cohort—regardless of when the final decision is made for  each of the applications in that year’s cohort. The agency’s performance as  measured against a fiscal year’s MDUFMA performance goals is  preliminary until all applications in a cohort are completed —and this can  take up to 3 or 4 fiscal years.
The two MDUFMA performance goals that FDA must meet for fiscal years  2003 and 2004 are tied to the same type of cycle action for different types of  applications. One performance goal applies to the cycle action taken on  PMAs, Panel- Track Supplements, and Premarket Reports, and the other  performance goal applies to Expedited PMAs. To meet each performance  goal, FDA must review the completeness of a manufacturer’s response to  an approvable letter pending minor corrections or clarifications and make  a decision within 30 days of receiving the manufacturer’s amendment. FDA  must meet this time frame on 90 percent of the applications for which it  takes a cycle action (see table 1).
In fiscal year 2005, 20 MDUFMA performance goals will become effective,  including the 2 performance goals that have been effective since fiscal year  2003 (see table 2).  The 20 performance goals will apply to eight types of  applications identified under MDUFMA and will be tied to other cycle  actions and decisions FDA makes on the applications during the review  process.
section_title: Limited Data to Measure FDA’s Performance against the MDUFMA Performance Goals
paragraphs: FDA had limited data that could be used to measure the agency’s  performance against most of the MDUFMA performance goals. Thus, it is  uncertain whether FDA will meet the MDUFMA performance goals for  fiscal years 2003, 2004, and 2005. For fiscal year 2003, the two performance  goals could be applied to 53 applications. However, as of March 31, 2004,  only one application was subject to a cycle action tied to one of the two  MDUFMA performance goals. In its review of that application, FDA  determined that the manufacturer provided a complete response to an  approvable letter pending minor corrections or clarifications and made the  decision to approve the application within the goal’s time frame. For fiscal  year 2004, there were no applications subject to the cycle action tied to the  two fiscal year 2004 MDUFMA performance goals. In addition, the  likelihood of FDA meeting the fiscal year 2005 MDUFMA performance  goals is uncertain because FDA had performance data for some, but not all,  of the MDUFMA performance goals that will be effective in fiscal year 2005.  FDA’s performance results could change as the agency completes its  actions on all applications for which the performance goals apply.
subsections: section_title: Limited Data to Measure FDA’s Performance against the MDUFMA Performance Goals Established for Fiscal Years 2003 and 2004
paragraphs: Limited data exist to measure FDA’s performance against the two  MDUFMA performance goals established for fiscal years 2003 and 2004.  Our analysis shows that FDA received 43 PMAs, 7 Panel-Track  Supplements, and 3 Expedited PMAs in the fiscal year 2003 cohort. As of  March 31, 2004, one application—an Expedited PMA—had been subject to  the cycle action tied to one of the two MDUFMA performance goals for  fiscal year 2003. In its review of this application FDA determined that the  manufacturer submitted a complete response to an approvable letter  pending minor corrections or clarifications, and approved the application  within 30 days. For PMAs and Panel-Track Supplements, the same  MDUFMA performance goal applied for fiscal year 2003. However, FDA did  not have any applications that required the issuance of an approvable  letter. Similarly, none of the 15 PMAs, 1 Panel-Track Supplement, and 8  Expedited PMA applications from the fiscal year 2004 cohort required  issuance of approvable letters.
Many of the applications from the fiscal years 2003 and 2004 cohorts were  pending within the review process for FDA review actions or  manufacturers’ responses to FDA. Therefore, FDA’s performance results  are preliminary. In the fiscal year 2003 cohort, 21 of the 50 PMAs and Panel- Track Supplements and 1 of the 3 Expedited PMAs FDA received were  pending as of March 31, 2004. Similarly, in the fiscal year 2004 cohort, 13 of  the 15 PMAs, 1 Panel-Track Supplement, and all 8 of the Expedited PMAs  FDA received were pending action. Because FDA’s performance against the  MDUFMA performance goals is based on the percentages of actions the  agency takes on applications within required review times, FDA’s  performance results could change as the agency completes actions on all  applications for which the performance goals apply. Data were not readily  available from FDA on the status of all pending applications within the  review process. FDA anticipates having complete data by the end of fiscal  year 2004.
section_title: Limited Performance Data to Determine the Likelihood of FDA Meeting the Fiscal Year 2005 MDUFMA Performance Goals
paragraphs: The likelihood of FDA meeting the MDUFMA performance goals for fiscal  year 2005 is uncertain because data to measure the agency’s performance  are limited. Specifically, FDA had data that allowed us to compare its  performance against some, but not all, of the 20 MDUFMA performance  goals that will be effective in fiscal year 2005. For example, from the fiscal  year 2003 cohort, data were available to compare FDA’s performance  against 17 of the 20 performance goals for fiscal year 2005. FDA took  actions on applications tied to 14 of the 17 performance goals within the  established goal time frames. For 7 of the 14 performance goals, FDA’s  performance was based on one or two actions on applications. FDA did not  take actions within the established goal time frames on applications tied to  3 of the 17 performance goals. Similarly, from the fiscal year 2004 cohort,  FDA had data for 11 of the 20 MDUFMA performance goals. We found that  FDA took actions on applications tied to each of the 11 performance goals  within the established goal time frames. For 4 of the 11 performance goals,  FDA’s performance was based on no more than three actions on  applications. (See table 3.)
As previously mentioned, many of the applications from the fiscal years  2003 and 2004 cohorts are awaiting actions by FDA or responses from  manufacturers. Our analysis of the applications pending within the review  process shows that of the 4,175 applications received in the fiscal year 2003  cohort, 339, or 8 percent, were pending further action by FDA as of   March 31, 2004. Of the 1,781 applications received in the fiscal year 2004  cohort, 859, or 48 percent, were also pending as of March 31, 2004. The  number of applications pending varied by application type. (See table 4.)   For example, in the fiscal year 2003 cohort, 21—or 42 percent—of the 50  PMAs and Panel-Track Supplements were pending, while 316—or 8  percent—of the 3,914 510(k)s were pending further action by FDA. As FDA  completes its actions on more applications, its performance results could  change.
According to FDA officials, in fiscal year 2003, FDA began implementing  activities that are intended to enhance its ability to meet MDUFMA  performance goals that become effective in fiscal year 2005. These  activities, identified in the Secretary of HHS’s November 2002 letter  establishing the MDUFMA performance goals, include hiring additional  staff, consulting with experts outside the agency more frequently, and  holding meetings with manufacturers to ensure high-quality applications  are submitted to FDA. For example, in fiscal year 2003, CDRH hired staff  for 67 new positions, such as medical officers, scientists, and engineers, to  improve the timeliness of its device reviews. As of April 2004, CDRH filled  23 of the 65 positions it plans to fill in fiscal year 2004. CBER also filled  each of the 11 full-time equivalent positions that it received in fiscal year  2003 and planned to fill 9 full-time equivalent positions during fiscal year  2004 to improve the timeliness of device reviews as well as other activities. In addition, to help FDA meet its performance goals, FDA held  about 100 meetings with manufacturers to discuss ways to improve the  quality of applications prior to their submission.
section_title: FDA Obligated over $128 Million for Postmarket Medical Device Compliance Activities and Inspections in Fiscal Year 2002
paragraphs: In fiscal year 2002, FDA obligated about $128 million for postmarket  medical device compliance activities, which include inspections of device  manufacturers’ establishments. FDA obligated about $109 million for  compliance activities and about $19 million for inspections. Of the  approximately $109 million, FDA obligated about $99 million for  postmarket compliance activities that encompass outreach coordination,  applied research, and laboratory analyses. Outreach coordination included  funds for guidance to field staff on matters such as the reporting of  problems with medical devices, epidemiology studies, device recalls, and  other activities. Obligations for applied research included funding for  activities such as the development of domestic and international standards  to help provide reasonable assurance that medical devices are safe and  effective. Obligations for laboratory analyses included funding for activities  such as FDA laboratory-based investigations and scientific training for FDA  inspection staff. FDA also obligated an estimated $10 million in rental  expenses for office space for FDA staff who conduct compliance  activities.
In fiscal year 2002, of the $19 million obligated for inspections, FDA  obligated about $17 million for inspections of domestic and foreign  establishments and about $2 million in estimated office space rental  expenses for FDA staff who conduct inspections. These inspections  included routine surveillance inspections to determine compliance with  medical device regulations, inspections resulting from the reporting  problems with devices or product recalls, and compliance inspections to  collect evidence for pending enforcement actions.
section_title: Agency Comments
paragraphs: In commenting on a draft of this report, FDA generally agreed with our  findings. FDA stated that it believes the agency has made a good start in its  implementation of MDUFMA and FDA believes that its progress in meeting  the MDUFMA performance goals is consistent with the extensive  performance improvements the agency is expect to achieve each year  through 2007. FDA provided technical comments primarily clarifying  aspects of the medical device review process, which we incorporated as  appropriate. FDA’s comments are reprinted in appendix I.
We are sending copies of this report to the Secretary of HHS and the  Commissioner of FDA, appropriate congressional committees, and other  interested parties. We will also make copies available to others on request.   In addition, the report is available at no charge on the GAO Web site at  http://www.gao.gov. If you or your staffs have questions about this report,  please contact me at (202) 512-7119 or James McClyde at (202) 512-7152.   Darryl Joyce, Donna Bulvin, and Krister Friday also made key  contributions to this report.
section_title: Comments from the Food and Drug Administration
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