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 329 21ST CENTURY CURES Capping nearly two years of AdvaMed advocacy, in December Congress passed and the president signed the 21st Century Cures Act, designed to accelerate the discovery, development and delivery of 21st century cures for patients in need. AdvaMed played a prominent role – working in concert with many allied stakeholder groups – in proposing and advancing key provisions of the legislation that will help continue improvement of FDA regulatory processes. Key elements include a breakthrough pathway provision that will improve use of the agency’s Expedited Access program. There are also provisions that: raise the humanitarian device exemption cap; establish a process for FDA recognition of international standards; improve selection of experts on FDA advisory panels; update the Class I/II exemption list; allow for the use of central institutional review boards for device trials; require FDA to update its CLIA-waiver guidance; reinforce FDA’s use of the “least burdensome” principle in conducting reviews; clarify FDA regulation of software and certain digital health tech- nologies; and improve the regulation of combination products. AdvaMed’s leadership in assisting development and advancement of this important legislation included Board member participation in multiple congressional roundtables and hearings that informed the legislative process. FDA Commissioner Robert Califf (at left) discusses agency priorities with T&R Board Committee Chairman Gary Pruden of Johnson & Johnson (center) and AdvaMed’s Scott Whitaker (at right) at the Association’s June Board meeting in Washington, D.C. CDRH Director Jeffrey Shuren (at left) and other senior agency leaders participate in a “CDRH Town Hall” moderated by AdvaMed’s Janet Trunzo (at right) at the AdvaMed 2016 conference in October in Minneapolis.