The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.
While US FDA's new draft guidance on the "concepts and principles" of the least burdensome provisions was prompted in part by last year's enactment of the 21st Century Cures Act, it is intended to go further than that, says device-center director Jeffrey Shuren.
"The approach that we are taking on least burdensome goes beyond what Congress has put into the law," Shuren told...
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
