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11th Annual FDA/AdvaMed Medical Devices And Diagnostics Statistical Issues Conference

May 9, 2018 to May 10, 2018
Washington, DC

Join  us  for  the  11th  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  to  include  real  world  evidence;  statistical  versus  clinical  significance;  multiple  data  sources;  reader  studies  and  agreement. 

The 11th Annual Medical Devices and Diagnostics Statistics Conference is co-hosted with: 

The reception following the first day of the conference will feature a poster session:

  • Posters due April 30 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 and full details about the poster session.

Please note there is a "Day 0" additional related workshop, taking place the day prior to  this conference.  This year's Day 0 topic is Precision Medicine: Statistical Challenges and Opportunities. Professionals often attend both the workshop and the conference.  Additional information and registration about this "Day 0" workshop can be found here.

Click here to view and download the agenda

Topics will include:

  • Utilizing Real World Evidence in Medical Device Evaluation
  • Statistical versus Clinical Significance
  • Statistical Analysis of Multiple Data Sources
  • Applying the Least Burdensome Principles to Clinical Study Designs
  •  Analytical Studies for Diagnostic Tests - Standards Update and Case Studies
  • Statistical Issues in Agreement Studies and Assessment of Reader Agreement
  • Precision Medicine – Statistical challenges
  • and much more!

Hotel & Meeting Logistics

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

Room Rate:  $349/night
Cutoff date for room reservations:  April 16, 2018
Reservation Link:

Registration Fees

AdvaMed Accel Member Registration: $695.00

AdvaMed Member Registration: $1,295.00

FDA Registration: $250.00

Non-Member Registration: $1,595.00

Cancellation and Refund Policy
All cancellations must be received via email to (link sends e-mail). Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows". 

We welcome substitutions in lieu of cancellations at any time. Please contact us at (link sends e-mail) with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.

Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.