The US FDA recently launched a new website, with a new look and organization. It is certainly better than the old site, but it still could use some improvement in the way information for consumers versus industry is presented. In any case, check out the medical devices section of the new FDA site for yourself . Also see the revised section with FDA Guidance Documents. k3jt6excvi
The EU has just released an important guidance document that should be read by every company selling medical devices in Europe. It provides guidance on an amendment to the original Medical Devices and Active Implantable Medical Devices Directives. Probably the most important part of the 2007/47/EC guidance for medical device companies is that the amended directive goes into effect on 21 March 2010 and there will be no transitional period. This means that companies must comply by March 21. There are other points you should read about as well. You can download the entire 2007/47/EC guidance document and read our analysis of the changes made by 2007/47/EC to 93/42/EEC on our website.
Regulatory Affairs | Chris Schorre, Emergo Group June 25, 2009 | 
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