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HEHS-94-90R 1 (1994-02-02)

handle is hein.gao/gaobackmf0001 and id is 1 raw text is: G~~ United States General Accounting Office Washington, D.C. 20548 Human Resources Division B-256222 February 2, 1994 The Honorable Ron Wyden Chairman, Subcommittee on Regulation, Business Opportunities, and Energy Committee on Small Business House of Representatives Dear Mr. Chairman: In your letter of February 5, 1993, you expressed concern that the Food and Drug Administration (FDA) may be taking too long to review and approve safety devices designed to protect health care workers from injury and exposure to blood-borne infections. You also raised several questions about the extent to which the Department of Veterans Affairs (VA) is using new and safer needle and sharps devices and whether the cost of these devices has inhibited VA from purchasing them. This letter addresses FDA's process for reviewing safety devices. In brief, we found that time spent by FDA reviewing applications for these devices increased by 147 percent from fiscal year 1992 to fiscal year 1993, mainly because the FDA branch that reviews these applications experienced significant staff attrition. This, in turn, has caused a backlog of applications awaiting review. FDA has hired additional staff and is attempting to reduce the time it spent in the review process. It has also established a goal of July 1994 for eliminating its backlog. In a subsequent report, we will address the remaining questions you raised concerning VA's use of safer needle and sharps devices. Background The Federal Food, Drug and Cosmetic Act, as amended, requires manufacturers to report to FDA at least 90 days before marketing a new device. Such a report must include a description of the device and whether the manufacturer is claiming that it is substantially equivalent to a device already being marketed. To determine whether a device is substantially equivalent, FDA requires manufacturers of most GAO/HEHS-94-90R FDA Safety Devices

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