The FDA published « Refuse to Accept Policy for 510(k)s » in August 2015, a new guidance document for medical device manufacturers. It aims at helping manufacturers of class II MD (mainly), to properly prepare and submit their 510(k) submissions to get approval in the...
With the deadline for UDI compliance quickly approaching (Sept 2015 or Sept 2016 according to the FDA extension list), the FDA began accepting GUDID account requests from labelers of implantable, life-supporting, and life-sustaining medical devices on January 26,...
The new RED directive about radio-electric equipment was published. It will be mandatory from June 2016. The new 2014/53/EU directive, of the European Parliament and of the Council, of the 16th of April 2014, defines the marketing rules for radio-electric equipment...
In March 2015, the FDA published a guide, written in question/answer form, intended to outline the use of electronic media, and the processes used to obtain electronic informed consent from participants (or their representatives) in a clinical investigation. This...
UDI System
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