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10th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference

April 26, 2017 to April 27, 2017
Washington, DC
Diagnostics, Digital Health


Join us to celebrate our 10th year of the Annual FDA-AdvaMed Medical Devices and Diagnostics Statistics Conference. This annual conference brings together leading authorities from FDA, industry and academia to address statistical topics through two tracks- therapeutic device and diagnostics.

Topics to be covered this year include:

General Sessions 

  • Real world evidence (RWE)
  • Guidances
  • Effective FDA/Industry Communication 

Therapeutic Track

  • Bayesian and Adaptive Designs 
  • Heterogeneity Issues in Clinical Trials
  • Statistical Challenges in Trial Design 1
  • Statistical Challenges in Trial Design 2 Related to Data Quality Improvement

Diagnostic Track

  • In Vivo Diagnostics 
  • Analytical studies
  • Companion Diagnostics (CDx) 
  • Emerging technologies and precision medicine 

The reception following the first day of the conference will feature a poster session, co-hosted by AdvaMed and the American Statistical Association (ASA):

  • Posters due April 10 at 11:59 p.m. EST.  Submit posters to
  • Submit an electronic version of the poster (eg as .ppt or .pdf file)
  • Posters will be judged on statistical innovation, applicability to medical devices and diagnostics, clarity of presentation, effective use of graphics, appropriate example(s) used, and overall impression 

Click here for more information on the poster session.

Please note there is an additional related workshop, co-hosted by AdvaMed and the American Statistical Association (ASA) Medical Device and Diagnostic Section, is taking place the day prior to  this conference, "Statistics Conference Day Zero - Sample Size Calculations For Statistical Testing". Professionals often attend both the workshop and the conference.  Additional information and registration about this "Day 0" workshop can be found here.

The 10th Annual Medical Devices and Diagnostics Statistics Conference is co-hosted with:


Event Logistics

Hotel & Meeting Logistics

Washington Marriott at Metro Center
775 12th St NW, Washington, DC 20005
(202) 737-2200

Room rate: $339.00
Cutoff date for reservations: Monday, April 3, 2017
Click here to reserve your room

Additional Info

Registration Fees

AdvaMed Accel Member Registration: $695.00

AdvaMed Member Registration: $1,295.00

FDA Registration: $250.00

Non-Member Registration: $1,295.00