Ambiguity from FDA Stunts Growth in the US, While Innovation Flourishes in Europe

Posted 23 July 2013 By Christopher J.P. Velis

Inconsistency and ambiguity in the US Food and Drug Administration's (FDA) regulatory process have created an environment of uncertainty in the medtech industry, stunting investment and slowing critical scientific advances. As a result of this confusion, investors are shy to support breakthroughs; the US risks losing its edge-and its market share-to regions with more fluid, predictable approvals.

Share this article:

Categories: US, FDA

Tags: Perspective, 510(k), PMA, approval, innovation, EU, medical device, regulatory

Regulatory Exchange: Latest Updates From the Community