The U.S. government must also organize to speak coherently as a sovereign nation on the issues of standards and conformity assessment, both internally and externally. This is particularly important in view of the new responsibilities and accountability of the sovereign government signatories to the Uruguay Round. Finally, the cost of standardization should be borne by those who gain value from the activity.

Many conference participants agreed that the United States must support an infrastructure that is competent, equitable, and credible. Some expressed the view that ANSI and the voluntary standards system should not be governed and funded by the present mixture of government, associations, standards developers, and a small percentage of industrial firms in the United States. This represents an uneven and inequitable distribution of governance and of financial support. A private-sector panelist maintained that revenue must be derived from value received and that ANSI should concentrate on activities that are of value, identifying who values them, and assessing revenue sources from that value structure.

The future will be substantially different from the past. Both private and public leaders need to seek improvements to the U.S. standards system in a way that involves the government. One participant pointed out that undesired levels of government control, which may accompany government involvement in private activities, can be mitigated through negotiation.

Industry–Government Cooperation in Regulation and International Standards

The medical device industry and the Food and Drug Administration (FDA) have developed and implemented a program to provide industry access to effective mechanisms to influence international standards, regulations, and trade. This program has been built on cooperation between industry and government. In 1989, the U.S. medical device industry instituted a program to influence international and European Community standards to promote harmonization of medical device standards and regulations. The industry administers most national standards and almost all horizontal medical device international standards.

The program's success could not have been achieved without the support of the FDA, according to an industry panelist. The program was enhanced by the fact that the U.S. industry's standards were used by many foreign governments. With FDA's support, the industry adopted as national standards all of the international standards that it administers in the United States. FDA support was critical to the medical device association's involvement with an ISO technical committee that will write, interpret, and coordinate medical device quality system standards for the international community. It is also working to harmonize medical device standards and regulatory requirements for all countries worldwide.

FDA provided leadership, resources, and credibility to this exercise. FDA also provided scientific and political leadership to industry's efforts to influence



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