Medical devices include thousands of products, many of which have greatly contributed to the quality of health care. As devices have proliferated, so have public policies that affect them. The federal government intervened to promote three fundamental values: safety by federal regulation, innovation through federal funding of research and development, and access by providing services under Medicare. The policies generally coexisted without conflict. However, two recent developments—the advent of cost containment and the expansion of the tort liability system—present a potentially disruptive influence on these policies, and threaten to undermine the values they serve. Because cost restraints are inevitable and the tort system provides consumer protection, the challenge for policymakers is to reconcile them with the values of safety, innovation, and access. The proposals presented here seek to promote coordination to protect those values without imposing unacceptable costs on the health care system.

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