Although efforts to harmonize US and EU regulations for medical device trials and approvals are ongoing, it’s important for manufacturers on both sides to remain aware of the continuing differences and to conduct business accordingly.
In this article from Clinical Trials Advisor, Meg Bryant reports on commentary provided by Squire Sanders lawyers Maureen Bennett and Cristiana Spontoni at an FDAnews webinar last month about recent progress toward aligning US and EU clinical trials standards. The discussion included details about the regulatory environments in both countries, those areas most (and least) likely to see harmonization in the near future, and proposed changes designed to bring the two systems closer together.
"Device Sponsors Should Be Aware of Variations in EU, US Systems," Clinical Trials Advisor, Sept. 16, 2010. FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431, +1 (703) 538-7600, www.fdanews.com.