**GAO-07-882R**                      Published: Jun 25, 2007. Publicly Released: Jul 25, 2007.                  

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## Highlights

The Food and Drug Administration (FDA) is the agency responsible for ensuring the safety and effectiveness of medical devices--such as catheters and artificial hearts--marketed in the United States. As part of its regulatory responsibilities, FDA reviews applications submitted by medical device companies for devices they wish to market, including devices that are new or those that include modifications to already approved devices. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorized FDA, beginning in fiscal year 2003, to charge user fees for various types of device applications. User fees were intended to provide resources to FDA, to increase staffing for medical device reviews and speed the timeliness of reviews, in addition to resources otherwise provided through the annual appropriations process. Under MDUFMA, FDA is required to report to the congressional committees of jurisdiction annually on the implementation of the user fee program. FDA submitted financial reports that include information such as amounts collected from user fees, the costs of reviewing device applications, and staffing levels FDA dedicated to the review of medical device applications for each fiscal year from 2003 through 2005. In response to industry concerns about the need for more cost information, FDA supplemented these MDUFMA financial reports by reporting more detailed information on the estimated average cost of reviewing medical device applications in those 3 years. Industry has challenged the appropriateness of the methodologies FDA used to identify the total cost of the process for reviewing medical device applications and the average costs of reviewing various types of applications. Industry has also questioned the degree to which staffing of the device review process has increased since the enactment of MDUFMA. MDUFMA will expire on October 1, 2007, and Congress is currently deliberating its reauthorization. You asked us to review FDA's methodology for determining costs of the process of reviewing device applications, as well as changes in the staff levels dedicated to that process since MDUFMA was implemented. In this report, we evaluate (1) whether FDA's methodologies for identifying its annual costs of reviewing device applications and its method for allocating these costs among various application types are consistent with federal cost accounting standards, and (2) the extent to which staffing levels for the process of reviewing device applications have changed since fiscal year 2002, the baseline year before MDUFMA went into effect, and how these changes in staffing levels have been distributed within FDA.

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## Topics

Auditing and Financial Management

Cost analysisFinancial statement auditsFinancial statementsMedical equipmentMedical technologyRegulatory agenciesReporting requirementsUser feesMedical devicesCost accounting