Evangeline Loh and Stewart Eisenhart If recent research is to be believed, European medical devic

Evangeline Loh and Stewart Eisenhart

If recent research is to be believed, European medical device regulatory review models are bringing products to market in significantly less time and at less cost than the United States. The U.S. regulatory process overseen by the U.S. Food and Drug Administration (FDA) long has served as a benchmark for other regulatory bodies due to the agency’s perceived high standards in terms of safety and efficacy.

According to recent medical device industry studies, however, a combination of external market factors and self-inflicted inefficiencies now threaten to both diminish the FDA’s standing as a global regulatory leader and hinder or delay U.S. patient access to cutting-edge devices approved faster and at less cost in Europe. Ongoing deliberations by the FDA on whether to make its 510(k) premarket notification process more exacting only have added to industry concerns, and may further prompt manufacturers to seek other markets (particularly Europe) in which to develop and commercialize their products. The U.S. medical device market’s loss of dominance is, however, in no way a foregone conclusion—recently announced agency efforts to expedite pioneering high-risk device approvals indicate at least some level of sensitivity to industry grievances—but until the regulator can build greater efficiency into its clearance and approval processes, the European Union and other markets only stand to gain at the United States’ expense.

Medical device manufacturers and industry advocates interested in product commercialization should bear in mind these apparent advantages of the current E.U. regulatory environment, especially relative to that of the United States.