Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 328 Ensuring regulatory processes for medical technology that are efficient, predictable and transparent is essential for innovation to thrive and patients to benefit, and is the core focus of AdvaMed’s Technology and Regulatory Affairs department. Our team of regulatory experts works collaboratively with our members, and with FDA and its counterparts around the world, to help ease the often challenging regulatory path to market – from clinical trials and premarket reviews to post-market require- ments – so that patients and physicians can have timely access to safe and effective innovations that save and improve lives. CONGRESSIONAL INNOVATION INITIATIVES In 2015, the T&R department leveraged its strong working relationships with FDA staffers at all levels to help develop and advance legislative proposals as part of the 21st Century Cures initiative in the House Energy and Commerce Committee, to increase the efficiency and predictability of the FDA review process and improve patient access to the best in medical progress. This effort paid off with House passage in July of the 21st Century Cures Act, including provisions to: •  Establish an expedited pathway for breakthrough technologies; •  Clarify valid scientific evidence requirements; •  Improve the standards recognition process; •  Allow the use of central institutional review boards to facilitate the conduct of multicenter clinical trials; and •  Revitalize the “least burdensome” standard for regulatory reviews. Meanwhile, AdvaMed sought to advance similar provisions under the parallel Healthier Americans initiative in the Senate Health, Education, Labor and Pensions Committee. USER FEE REAUTHORIZATION AdvaMed continued to monitor implementation of the FDA user fee agreement of 2012, under which the agency committed to a number of strong, measurable performance goals to increase the efficiency and consistency of its review process. Achievements to date include significant improve- ments in PMA and 510(k) review times, and in approval times for investigational device exemption studies. LIGHTINGA PATH FOR INNOVATION T E C H N O L O G Y A N D R E G U L A T O R Y A F F A I R S Improving FDA’s regulatory processes so that the cost and time of development and approval of devices and diag­ nostics is reduced and the CDRH mis­ sion statement that American patients will be the first in the world to have access to new devices is achieved, while maintaining the highest standards of safety and efficacy. INNOVATION AGENDA PILLAR 1 AdvaMed Technology and Regulation Board Committee Chairman Gary Pruden, worldwide chairman, medical devices, at Johnson & John- son, opens a CDRH Town Hall meeting at AdvaMed 2015 in San Diego. Donald St. Pierre, deputy director, new product evaluation, at CDRH’s Office of In Vitro Diagnostics and Radiological Health (at left); William Maisel, deputy director for science and CDRH chief scientist; and Jan Welch, deputy director for regulatory affairs at CDRH’s Office of Compliance, discuss regulatory proposals with AdvaMed members and staff in January. A D V A M E D 2 0 1 5 A N N U A L R E P O R T