Planning Your Launch Amid the US/EU Regulatory Convergence

Posted by Kate Templeton on January 4, 2018

Dan Frey and Barun Maskara co-wrote this blog post with Kate Templeton. 

Five to 10 years ago, many medium- and high-risk medical devices were expected to be commercialized first in Europe, with U.S. approvals lagging years behind. Industry leaders often criticized the FDA for inconsistently enforcing sometimes unclear regulations, and lamented that the lengthy and unpredictable U.S. approval timelines were driving innovation overseas.


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