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 In preparation for anticipated reauthorization of the user fee agreement in 2017, AdvaMed engaged in discussions with members and other stakeholders to identify data needs and develop strategic framework goals for negotiations. These goals include: pre-submission process improvements; goals for timing between a PMA “approvable” decision and issuance of an approval order; goals for de novo applications; improve- ments in the CLIA-waiver process and goals; and continuation of the independent assessment required under the previous agreement. Negotiations with FDA for user fee agreement reauthorization commenced in September. GUIDANCE DEVELOPMENT AdvaMed also met with FDA staff throughout the year to ensure consideration of important member goals as part of the agency’s development of several future guidance documents addressing the following topics: when to file a new 510(k) for a device modification; issues related to use of color additives in medical devices and colorant information requirements; and the type of modifications made to medical device software that require new 510(k) submissions. Bill MacFarland, director, CDRH Division of Enforcement B, Office of Compliance (at right) and Kim Lewandowski-Walker, FDA Office of Regulatory Affairs, national expert investigator, discuss the case for quality at the AdvaMed 2015 conference in San Diego. Janet Trunzo, AdvaMed senior executive vice president, technology and regulatory affairs (at right) leads a discussion of regulatory proposals with CDRH Director Jeffrey Shuren. Michael Mussallem, chairman and CEO of Edwards Lifesciences (at right), discusses the need for regulatory and other reforms with Senator Bill Cassidy of Louisiana, prior to providing formal testimony before the Senate Committee on Health, Education, Labor & Pensions.