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 A D V A M E D 2 0 1 6 A N N U A L R E P O R T REGULATION THAT WORKS From clinical trials and premarket reviews to post-market requirements, medical technology companies navigate an often challenging regulatory path to provide physicians and patients timely access to life-changing innovations. AdvaMed’s Technology and Regulatory Affairs department works with our members, FDA and its counterparts around the world, to help light the path to market and ensure regulatory processes that are efficient, predictable and transparent. In 2016, the department’s signature accomplishments included spearheading successful negotiation of a pro-innovation FDA user fee reauthorization agreement, and congressional passage of 21st Century Cures legislation with a robust slate of pro-innovation reforms. USER FEE REAUTHORIZATION In preparation for reauthorization of the Medical Device User Fee Act (MDUFA) in 2017, and to continue to build on meaningful FDA reforms already achieved under MDUFA III, AdvaMed engaged in discussions with members and other stakeholders for nearly a year to identify data needs and develop strategic framework goals for negotiations with the agency. These negotiations culminated in an August reauthorization agreement between industry and FDA to continue to improve the efficiency, predictability and transparency of review processes. Key improvements in the agreement include: • Significant reductions for total review time goals for 510(k)s and PMAs, and first-time goals for de novo products; • Reforms to increase the consistency and timeliness of the review process, including FDA’s commitment to provide feedback to a company at least five days before a pre-submission meeting and a requirement for FDA to document the rationale for issuing a deficiency letter; and • Greater accountability through two independent analyses of the agency’s management of the review process, and imple- mentation by FDA of a quality system management approach. Successful implementation of the agreement, once enacted through legislation, will advance the mutual goals of industry and FDA to provide health care professionals and patients more timely access to the life-changing innovations our members provide. u T E C H N O L O G Y A N D R E G U L AT O R Y A F F A I R S T&R Board Committee Chairman Gary Pruden of Johnson & Johnson (at left) addresses AdvaMed 2016 conference attendees, alongside Nadim Yared of CVRx (at right). John Sheets, director of CDRH’s office of device evaluation (center), and William Maisel, deputy director for science and CDRH chief scientist (at right), meet with AdavMed’s Janet Trunzo (second from left) and members, including Pat Shrader of Medtronic (at left) and Michael Pfleger of Alcon (second from the right), in September.