The US FDA is launching the Medical Device Innovation Initiative to make new medical devices available more quickly for patients. This broad initiative will promote early interaction between the FDA and industry to optimize review times and foster innovation. As outlined in a report released by the Agency, the Centre for Devices and Radiological Health (CDRH) will expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least burdensome approach to clinical trials. This initiative builds on CDRH’s strong scientific foundation and additional resources for the device review program provided under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).