Medical device regulation in the European Union, Japan and the United States. Commonalities, differences and challenges

The evolution and diversity of institutions across the United States, the EU and Japan, and the timing of the medical device framework splitting off from the drug regulatory framework, are striking. Regulatory agencies face a new landscape: the combination of industry-paid user fees and appropriations, and a general pro-business climate coupled with dramatic advances in medical technology, shortage in skilled experts trained in the latest state-of-the-art science, and necessary legal and administrative changes. This paper seeks explanations for the complex structure of medical device regulation by focusing on the meaning of the “life cycle” concept, opportunities for patient voices, and the scope of, and potential for conflicts of interest of, industry, physicians, scientific advisors and regulatory authorities. The paper concludes that the initial international differences between medical device frameworks tend to be mitigated by voluntary global harmonization, but that actual, effective integration into the national regulatory framework significantly depends on each nation's and the EU's embedded norms, rules and procedures, and politics.