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13th Annual FDA/AdvaMed Medical Device Statistics Issues Conference

May 10, 2021 to May 12, 2021
Conference, Webinar

Please join us virtually from May 10-12, 2021 for the 13th Annual FDA/AdvaMed Medical Device Statistics Issues Conference. This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. New in this year’s virtual format, dedicated therapeutic and diagnostic-themed sessions will run on consecutive days, rather than concurrently as in years past. Attendees will have access to all therapeutic and diagnostic sessions across this three-day event. With daily networking receptions and breakout discussions, this conference provides the opportunity to meet and converse with peers, industry leaders, FDA representatives and more. 

Click here to register for the 13th Annual FDA/AdvaMed Medical Device Statistics Issues Conference. Register before Friday, April 30 to save 15%. Please see below for more details.

Session Topics Include:

  • Global Harmonization
  • Leveraging Real World Data and Historical Data
  • Long-Term Safety Assessment
  • Two-Phase Study Design
  • Clinical Outcome Assessment
  • Artificial Intelligence/Machine Learning in Digital Health
  • Emerging Intended Uses for Diagnostic Devices
  • Analytical Study Issue

Click here to view the agenda



  • Dr. William Maisel, Chief Medical Officer and Director, Office of Product Evaluation and Quality, FDA/CDRH
  • Scott Berry, Berry Consultants
  • Yun-Ling Xu, FDA/CDRH
  • Greg Campbell, GCStat Consulting, LLC
  • Vandana Bhatia, FDA
  • Theodore Lystig, Medtronic
  • Lilly Yue, FDA
  • Jithesh Veetil, MDIC
  • Vandana Bhatia, FDA
  • Keneth Cavanaugh, OPEQ/CDRH/FDA
  • Mailin Hesse, Abbott Germany
  • Jaap Laufer, Emergo
  • Nelson Lu, FDA/CDRH
  • Tim Hanson, Medtronic
  • Scott Snyder, Cook Medical
  • Chenguang Wang, Johns Hopkins University
  • Heng Li, FDA
  • Songtao Jiang, Boston Scientific
  • Chia-Wen (Kiki) Ko, CDRH/FDA
  • Tyson Rogers, NAMSA, Inc.
  • Michelle Tarver, FDA/CDRH/OST
  • Samuel F. Sears, East Carolina University
  • Daniel Serrano, Pharmerit
  • Gail Kongable, Abbott Rapid Diagnostics
  • Mark Weinheimer, Abbott Rapid Diagnostics
  • Arkendra De, FDA/CDRH/OPEQ
  • Zhiheng Xu, FDA
  • Meijuan LI, Foundation Medicine
  • Paul Wenz, Illumina
  • Zhiheng Xu, FDA
  • Meijuan Li, Foundation Medicine
  • Kristen Meier, Illumina
  • Marina Kondratovich, FDA/CDRH
  • Shuguang Huang, Stat4ward, LLC
  • Chunrong Cheng, FDA/CBER


Pricing/Registration Fees:

    • AdvaMed Member registration: $975.00
    • AdvaMed Accel registration: $525.00
    • Government and Non-Profit registration: $250.00
    • Non-member registration: $1,200.00

    Early-bird pricing is available! Register before Friday, April 30 to save 15%


    Group Discounts:

    AdvaMed member companies with 3 or more registrants of the conference may use the code STATSGROUP to save an additional 10% off the AdvaMed Member rate*

    *Discounts must be applied at the time of registration.


    Click here to learn more about the benefits of becoming an AdvaMed member.