If eligible, a 510(k) is filed when a manufacturer seeks a determination  that a new device is substantially equivalent to a legally marketed device  known as a predicate device. Under MDUFA, FDA’s goal is to complete the  review process for 90 percent of the 510(k)s in a cohort within 90 days of  submission (known as the Tier 1 goal) and to complete the review process for 98 percent of the cohort within 150 days (the Tier 2 goal). The PMA review process is  the most stringent type of medical device review process required by  FDA, and user fees are much higher for PMAs than for 510(k)s. PMAs  are designated as either original or expedited. FDA considers a device  eligible for expedited review if it is intended to (a) treat or diagnose a life- threatening or irreversibly debilitating disease or condition and   (b) address an unmet medical need.submissions to determine which are appropriate for expedited review,  regardless of whether a company has identified its device as a potential  candidate for this program. FDA’s review of medical device submissions has been discussed in  recent congressional hearings, meetings between FDA and stakeholders  about the medical device user fee program reauthorization, and published  reports. FDA Met All Performance Goals for 510(k)s but the Time to Final Decision Has Increased Substantially in Recent Years

For FYs 2003 through 2010, FDA met all Tier 1 and Tier 2 performance  goals for 510(k)s. In addition, FDA review time for 510(k)s decreased  slightly during this period, but time to final decision increased  substantially. 3). However, when we added off-the- clock time (where FDA waited for the sponsor to provide additional  information) to FDA’s on-the-clock review time, the resulting time to final  decision decreased slightly from the FY 2003 cohort to the FY 2005  cohort before increasing 61 percent—from 100 days to 161 days—from  the FY 2005 cohort through the FY 2010 cohort. Additionally, although the 510(k) cohort for FY 2011 was still incomplete  at the time we received FDA’s data, the average FDA review time and  time to final decision were lower in FY 2011 for those submissions on  which it had taken action. 4). FDA Was Inconsistent in Meeting Performance Goals for PMAs While FDA Review Time and Time to Final Decision Generally Increased

For FYs 2003 through 2010, FDA met most of the goals for original PMAs  but fell short on most of the goals for expedited PMAs. In addition, FDA  review time and time to final decision for both types of PMAs generally  increased during this period. 7.) Specifically, average FDA  review time for original PMAs increased from 211 days in the FY 2003  cohort (the first year that user fees were in effect) to 264 days in the   FY 2008 cohort, then fell in the FY 2009 cohort to 217 days (see fig. Stakeholders Noted Issues with the Medical Device Review Process; FDA Is Taking Steps That May Address Many of These Issues

The industry groups and consumer advocacy groups we interviewed  noted a number of issues related to FDA’s review of medical device  submissions. The most commonly mentioned issue raised by industry and  consumer advocacy stakeholder groups was insufficient communication  between FDA and stakeholders throughout the review process. FDA has taken or plans to take several steps that may address issues  with the frequency and quality of its communications with stakeholders,  including issuing new guidance documents, improving the guidance  development process, and enhancing interactions between FDA and  stakeholders during reviews. Industry Stakeholders Report a Lack of Predictability and Consistency in Reviews

The three industry stakeholders that we interviewed also told us that there  is a lack of predictability and consistency in FDA’s reviews of device  submissions. Consumer Advocacy Group Stakeholders Suggest That FDA Provides Inadequate Assurance of the Safety and Effectiveness of Approved or Cleared Devices

Three of the four consumer advocacy group stakeholders with whom we  spoke stated that FDA is not adequately ensuring the safety and  effectiveness of the devices it approves or clears for marketing. Concluding Observations

While FDA has met most of the goals for the time frames within which the  agency was to review and take action on 510(k) and PMA device  submissions, the time that elapses before a final decision has been  increasing. It is important for the agency to monitor the impact of those  steps in ensuring that safe and effective medical devices are reaching the  market in a timely manner. Agency Comments

HHS reviewed a draft of this report and provided written comments, which  are reprinted in appendix III. HHS generally agreed with our findings and  noted that FDA has identified some of the same performance trends in its  annual reports to Congress. Appendix I: FDA Medical Device Review Performance for Fiscal Years (FY) 2000–2011

	of the Medical Device

2002 (MDUFMA) (MDUFA)
Cycles that were currently in progress at the time we received FDA’s data were included in this  analysis. Fiscal years for which there was no corresponding expedited PMA performance goal are denoted  with a dash (—).
Why GAO Did This Study

The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally subject to FDA review via the 510(k) process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires evidence providing reasonable assurance that the device is safe and effective. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorized FDA to collect user fees from the medical device industry to support the process of reviewing device submissions. FDA also committed to performance goals that include time frames within which FDA is to take action on a proportion of medical device submissions. MDUFMA was reauthorized in 2007.
Questions have been raised as to whether FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner. In preparation for reauthorization, GAO was asked to (1) examine trends in FDAs 510(k) review performance from fiscal years (FY) 2003-2010, (2) examine trends in FDAs PMA review performance from FYs 2003-2010, and (3) describe stakeholder issues with FDAs review processes and steps FDA is taking that may address these issues. To do this work, GAO examined FDA medical device review data, reviewed FDA user fee data, interviewed FDA staff regarding the medical device review process and FDA data, and interviewed three industry groups and four consumer advocacy groups.

What GAO Found

Even though FDA met all medical device performance goals for 510(k)s, the elapsed time from submission to final decision has increased substantially in recent years. This time to final decision includes the days FDA spends reviewing a submission as well as the days FDA spends waiting for a device sponsor to submit additional information in response to a request by the agency. FDA review time excludes this waiting time, and FDA review time alone is used to determine whether the agency met its performance goals. Each fiscal year since FY 2005 (the first year that 510(k) performance goals were in place), FDA has reviewed over 90 percent of 510(k) submissions within 90 days, thus meeting the first of two 510(k) performance goals. FDA also met the second goal for all 3 fiscal years it was in place by reviewing at least 98 percent of 510(k) submissions within 150 days. Although FDA has not yet completed reviewing all of the FY 2011 submissions, the agency was exceeding both of these performance goals for those submissions on which it had taken action. Although FDA review time decreased slightly from FY 2003 through FY 2010, the time that elapsed before FDAs final decision increased substantially. Specifically, from FY 2005 through FY 2010, the average time to final decision for 510(k)s increased 61 percent, from 100 days to 161 days.
FDA was inconsistent in meeting performance goals for PMA submissions. FDA designates PMAs as either original or expedited; those that FDA considers eligible for expedited review are devices intended to (a) treat or diagnose life-threatening or irreversibly debilitating conditions and (b) address an unmet medical need. While FDA met the performance goals for original PMA submissions for 4 out of 7 years the goals were in place, it met those goals for expedited PMA submissions only twice out of 7 years. FDA review time and time to final decision for both types of PMAs were highly variable but generally increased in recent years. For example, the average time to final decision for original PMAs increased from 462 days for FY 2003 to 627 days for FY 2008 (the most recent year for which complete data are available).
The three industry groups and four consumer advocacy groups GAO interviewed noted a number of issues related to FDAs review of medical device submissions. The four issues most commonly raised by stakeholders included (1) insufficient communication between FDA and stakeholders throughout the review process, (2) a lack of predictability and consistency in reviews, (3) an increase in time to final decision, and (4) inadequate assurance of the safety and effectiveness of approved or cleared devices. FDA is taking stepsincluding issuing new guidance documents, enhancing reviewer training, and developing an electronic system for reporting adverse eventsthat may address many of these issues. It is important for the agency to monitor the impact of those steps in ensuring that safe and effective medical devices are reaching the market in a timely manner.
In commenting on a draft of this report, HHS generally agreed with GAOs findings and noted that FDA has identified some of the same performance trends in its annual reports to Congress. HHS also called attention to the activities FDA has undertaken to improve the medical device review process.