Federal Regulation of Medical Devices--Problems Still To Be Overcome

Gao ID: HRD-83-53 September 30, 1983

GAO discussed the Food and Drug Administration's (FDA) efforts to regulate the medical device industry under amendments to the Food, Drug and Cosmetic Act, which require FDA to: (1) protect the public against unsafe or ineffective new devices gaining entry to the market; (2) review devices on the market before passage of amendments; and (3) classify all devices according to risk and regulate them.

GAO found that FDA does not have a comprehensive system to collect and analyze data on medical device problems or their causes and severity. The system focuses on problems with individual devices and has rarely been used to analyze trends with a particular group of devices. In addition, manufacturers and distributors are not required to notify FDA when they become aware of a death, injury, or hazard caused by a medical device. FDA could also use an improved information system to give the private sector better information on user and maintenance problems. Many device experts whom GAO interviewed questioned the feasibility and utility of developing standards for over 1,000 devices because standards do not ensure safe and effective devices and may be obsolete by the time they are developed. GAO found that: (1) FDA has not reviewed the devices which were on the market before 1976; (2) a large number of devices will be involved; and (3) the process is time-consuming. GAO also believes that the FDA review of risky new devices, on the basis that they are substantially equivalent to preenactment devices, is not effective, since FDA has not reviewed preenactment devices for safety and effectiveness, as required by the amendments.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

Director: David P. Baine Team: General Accounting Office: Human Resources Division Phone: (202) 512-7101


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