Medical device makers find new layer of regulation before earning CE Mark approval | Regulatory news for the week of August 4, 2014

Here's a look at some of the top regulatory stories for medical device companies this week: Medical device makers face new obstacles to European approval; FDA panel narrowly OKs Cohera Medical's TissuGlu; FDA cuts fiscal 2015 user fees; Catching up with the FDA's 2014 guidance; FDA panel votes against EDAP's ultrasound prostate cancer ablation

Medical device makers face new obstacles to European approval

July 30, 2014 by Arezu Sarvestani

Cohera Medical Inc., EDAP TMS SA, European Commission, Food & Drug Administration (FDA)

News Well, Regulatory/Compliance

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