The Food and Drug Administration (FDA) reviews the safety and effectiveness of new medical devices sold in the United States, and The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorizes FDA to collect user fees to support the device submission review process. MDUFMA also establishes performance goals for the FDA including time frames for action on medical device submissions.

In its report, FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer, the U.S. Government Accountability Office (GAO) examined FDA medical device review and user fee data, interviewing FDA staff, three industry groups, and four consumer advocacy groups. The GAO examined FDA 501(k) review performance trends and FDA PMA review performance trends between 2003 and 2010. The GAO also examined stakeholder issues with the review process employed along with steps the FTC used to address each. The study aimed to determine, in preparation for reauthorization, whether FDA met performance goals and whether devices reached the market in a timely manner.

The GAO found that the time involved between submission and final decision significantly increased in recent years, though 510(k) medical device performance goals were met. It was also determined that FDA was inconsistent in meeting both original and expedited PMA submission performance goals. The following four common stakeholder issues were noted following interviews with industry and consumer advocacy groups:

  • Insufficient communication throughout the review process between FDA and stakeholders.
  • Unpredictability and inconsistency in reviews.
  • Increased time required for final decision.
  • Inadequate safety and effectiveness assurance for cleared or approved devices.

In response to stakeholder issues, FDA is enhancing reviewer training, issuing new guidance documents, and developing an electronic reporting system for adverse events.

To read or download the full report, click here (PDF).