Medical Devices

International Medical Device Regulators Forum (IMDRF), September 15-19, 2014

A week of global meetings to discuss worldwide medical device regulation and harmonization efforts.

All interested parties are invited to attend many of the events throughout the week (some events are closed to invited members/regulators only). See below a full list of meetings, including a brief description of the event and the participation allowance. The events are centered around the mid-week plenary session of the IMDRF Stakeholders Meeting. During this meeting, participants will be invited to discuss continuous improvements to device safety and performance, and emerging challenges in medical device regulation. Stakeholder input is important to global harmonization, and the IMDRF Management Committee greatly appreciates your participation and contribution.

PLEASE NOTE: There is no fee to register for any of the events/meeting throughout the week. You must register for ALL events you wish to attend. Some events will be open ONLY to invited members and regulators, please only select those events if you received personal invitation. Attendees are responsible for all travel and lodging arrangements and all associated costs. All presentations will be given in English and translation will not be provided. Registration will be limited by space restrictions. Webcast will NOT be available.


Date, Time and Location

This week-long meeting event will be held at the Embassy Row Hotel in Washington, DC, on September 15-19, 2014. Individual meeting times will vary each day. All meetings will be held in the Embassy Row Hotel, specific meeting rooms will be posted inside the hotel. Only in-person attendance is available, meetings will not be webcast.

Meeting Location:
Embassy Row Hotel
2015 Massachusetts Avenue NW
Washington, DC 20036

Lodging Information

Embassy Row Hotel
2015 Massachusetts Avenue NW
Washington, DC 20036
Phone: 202-265-1600
Direct Reservation Toll-Free Phone:1-855-893-1011
Room Rate: $219.00 USD per room, per night
Name of Room Block: International Medical Device Regulators Forum - FDA Host

Events and Meetings

Monday, September 15, 2014:

DITTA International Standards: The Value and Mechanics of Medical Device Standards in the 21st Century -- [OPEN TO ALL REGISTRANTS]
Description:  A seminar to discuss the standards “lifecycle” from idea to implementation, including best practices, the future of international standards, and their impact on patient safety and innovation.

  • 8:30 a.m. - 5:00 p.m.
  • Lunch not provided
  • Agenda managed by DITTA, the global organization for the medical imaging, IT and radiation therapy industry

NOTE: This is a DRAFT Agenda, many speakers have not yet been confirmed.

8:00-8:30Welcoming Coffee and sign-in
8:30-8:35Introduction and Opening Remarks: Gail Rodriguez / DITTA Vice-Chair, MITA Executive Director (confirmed)
8:35-9:15Keynote Speech: FDA current use and vision of a broader application of standards in regulatory framework: Scott Colburn / FDA CDRH Director of Standards (confirmed)
9:15-10:30Value of International Standards and Impact
  • Healthcare practitioner’s view on impact on clinical outcomes: Dr. Dain / Chairman of ISO/TC 121/SC 4 (confirmed)
  • Regulator’s view on impact on patient safety: Scott Colburn / FDA CDRH Director of Standards (confirmed)
  • Industry view on impact on innovation: Peter Linders / DITTA (confirmed)
10:30-11:00Coffee Break
11:00-11:30Standards “lifecycle” from idea to implementation: Paul Molitor / NEMA (confirmed)
11:30-12:30Best practices: International standards used in convergence of regulatory requirements
  • Using and referencing ISO/IEC standards for regulatory purposes-ISO/IEC?: Norbert Bischof / IEC/TC62 (confirmed)
  • Country best practices for standards use:
    • Brazil – Lilian Orofino, ABIMED Advisory Board member (confirmed)
    • Canada – Cindy Evans / Health Canada (confirmed) 
    • Japan – Mr Koga / PMDA (confirmed)
12:30-1:30Lunch Break
1:30-3:00Breakout Sesssions
  • Standards development (moderator/chair-Norbert Bischof / IEC/TC62 (confirmed)
  • Mechanisms that surround standards (moderator/chair-Dave Osborn / Philips (confirmed)
  • Regulatory application of standards (moderator/chair - Mr. Koga / PMDA (confirmed)
3:00-4:15

Panel Discussion: Challenges and Opportunities for better use of International Standards

  • Moderator – Jeffery Gren / Gren International Health & Trade Consulting (confirmed)
  • Industry – Hans Beinke/Siemens and Mary Overland/GEHC / DITTA (confirmed)
  • Regulators – Scott Colburn / US FDA (TBC), Joanna Koh / AHWP (confirmed)
  • SDO – Norbert Bischof / IEC (confirmed)
4:15-4:30Closing plenary - Nicole Denjoy, Chair of DITTA, COCIR Secretary General (confirmed)
4:30-5:00Post Seminar Social Network

Pan American Health Organization (PAHO) Regulators Meeting: (Day 1) -- [OPEN ONLY TO INVITED REGULATORS]
Description: Regional Regulators Closed Discussion

  • 1:00 p.m. - 5:00 p.m.
  • Lunch not provided
  • Agenda managed by PAHO

Tuesday, September 16, 2014:

IMDRF Management Committee (MC) Meeting (Day 1) -- [OPEN ONLY TO MC MEMBERS]
Description:  IMDRF MC members will hold a closed meeting to discuss current work items.

  • 9:00 a.m. - 12:00 p.m.
  • Lunch for purchase (bag lunch available in meeting room)
  • Agenda managed by US Food and Drug Administration (FDA)

IMDRF Management Committee (MC) Meeting, with Invited Observers (Day 1 - PM) -- [OPEN ONLY TO MC MEMBERS and INVITED OBSERVERS]
Description: IMDRF MC members will host a meeting with invited guests to discuss current issues and work items.

  • 1:00 p.m. - 5:00 p.m.
  • Agenda managed by US FDA

PAHO Device Regulators Meeting (Day 2) -- [OPEN ONLY TO INVITED REGULATORS]
Description: Regional Regulators Closed Discussion

  • 8:30 a.m. - 12:00 p.m.
  • Lunch not provided
  • Agenda managed by PAHO

FDA Information Session (topics TBD) - [OPEN TO ALL REGISTRANTS]
Description: FDA leaders and regulatory experts will discuss topical issues in global medical device regulation, providing the FDA perspective and facilitating a group discussion.

  • 1:00 p.m. - 5:30 p.m.
  • Agenda managed by US FDA
1:00-1:10 p.m.Welcome & Opening Remarks - Bill Maisel, Deputy Center Director, CDRH
1:10-2:10 p.m.Patient Preferences Initiative - Moderator: Anindita Saha, Director of External Expertise and Partnerships, CDRH
FDA is working to determine ways to incorporate patient preferences on the benefit-risk trade-offs of medical devices into the full spectrum of the Center for Devices and Radiological Heath (CDRH) regulatory decision making.  This initiative also examines ways to advance the science of measuring treatment preferences of patients, caregivers, and health care providers.
2:10-3:10 p.m.Case For Quality Initiative - Moderator: Steve Silverman, Director, Office of Compliance, CDRH                               
Through the Case for Quality, the FDA is working with stakeholders—industry, healthcare providers, patients, payers, investors, and others - to foster medical device quality. This is achieved by identifying and promoting practices that result in high-quality devices and adapting FDA regulatory oversight approaches to align with those practices. Ultimately, this provides stakeholders with understandable and objective information about medical device quality; facilitates device innovation and quality; and fosters strategies that focus stakeholder interactions on device quality.  This discussion will provide an update on the progress of the initiative.
3:10-3:20 p.m.Break
3:20-4:20 p.m.Medical Device Innovation Consortium (MDIC) - Anindita Saha, Director of External Expertise and Partnerships, CDRH
MDIC is a public-private partnership developed to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices.  MDIC is an independent, nonprofit corporation that receives input from industry, government, and other nonprofit organizations to prioritize the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathway to market for these innovations.
4:20-5:20 p.m.National Medical Device Postmarket Surveillance System - Moderator: Tom Gross, Director, Office of Surveillance and Biometrics, CDRH
FDA recognizes that input and active participation from many key national and international stakeholders is necessary to strengthen medical device postmarket surveillance and that a national system cannot be implemented or achieved by the FDA alone.  In September 2012, CDRH issued a report entitled "Strengthening Our National System for Medical Device Postmarket Surveillance.”  This session will discuss progress on the creation of this system. 
5:20-5:30 p.m.Closing Remarks - Bill Maisel, Deputy Center Director, CDRH

Wednesday, September 17, 2014:

IMDRF Stakeholders Meeting - [OPEN TO ALL REGISTRANTS]
Description: IMDRF MC members will present on current working group progress and all stakeholders will be invited to provide feedback and discuss ideas for continuous improvements to medical device safety and performance.

  • 9:00 a.m. - 5:00 p.m.
  • LUNCH - Complimentary lunch for all participants, provided by DITTA (12:00-1:00)
  • Afternoon Breakout Sessions - attendees will rotate through all sessions (Topics TBD)
  • RECEPTION - Complimentary rooftop reception for all participants, provided by AdvaMed (6:00-8:00)
9:00 – 12:00Morning Session
  1. Introduction by IMDRF Chair
  2. Management Committee Member Regulatory Updates
    • Australia
    • Brazil
    • Canada
    • China
    • European Union
    • Japan
    • Russia
    • United States
10:00 – 10:20Coffee/Tea Break
10:20 – 12:00Continue Morning Session
  1. Overview of progress to date on work items
    1. Medical Device Single Audit Program (MDSAP) (Kim Trautman)
    2. National Competent Authority Report (NCAR) (EU MC Delegate)
    3. Regulated Product Submission (RPS) (Nancy Shadeed)
    4. Software as a Medical Device (SaMD) (Kim Trautman)
  2. Consideration of new work items proposals (NWIP)
    1. Development of common terminology and code related to     adverse event of medical device – Japan MC delegation
    2. Harmonization of Good Clinical Practices - GMTA
  3. Industry Presentation(s) –
  4. Questions and Answers on AM Session
12:00 – 13:00Lunch
13:00 – 16:00Workshops
  1. Three Interactive Workshops (RPS, UDI and Patient Registries)
    • (Each workshop will run 50 minutes with 10 minutes in between)
    • 13:00 – 13:50 – Workshop rotation 1 per color code on registrant's badges
    • 13:50 – 14:00 – Rotate to the next Workshop Station
    • 14:00 – 14:50 - Workshop rotation 2 per color code on registrant's badges
    • 14:50 – 15:00 – Rotate to the next Workshop Station
    • 15:00 – 15:50 - Workshop rotation 3 per color code on registrant's badges
    • 15:50 – 16:00 – Rotate to the next Workshop Station
    • 16:00 – 17:00 Workshop Overview and Conclusions
  2. Reconvene for workshop reports and Q & As
  3. Concluding remarks by IMDRF Chair
17:30Reception Sponsored by GMTA/AdvaMed

Thursday, September 18, 2014:

Global Harmonization Summit (Day 1) - [OPEN TO ALL REGISTRANTS]
Description: Representatives from regional regulatory harmonization organizations from around the world will discuss current and future regulatory harmonization activities to further worldwide patient access to safe and effective medical technology.

  • 9:00 a.m. - 5:00 p.m.
  • Complimentary Lunch provided by AdvaMed
  • Agenda managed by AdvaMed

9:00 a.m.

Welcome and Keynote Address by Mary Lou Valdez, FDA

 

 

Morning Session
Understanding Where We Have Been and Where We Are Going With Harmonization

Moderator:  Philipe AuClair, Senior Director. Regulatory Strategy and Advocacy, Abbott

David W Feigal, Jr., Partner, NDA Partners LLC

Mike Ward, Manager, Health Canada

Laurent Selles, Deputy Head of the Cosmetics and Medical Devices Unit, Directorate-General Health and Consumers, European Commission
 

12:00pm

Lunch

 

1:00-3:00pm

Afternoon Session Panel 1
Update on Current Harmonization Activities

Moderator: Scott Sardeson, International Regulatory and Compliance Leader, 3M                                

Panelists: 
Lindsay Tao, Vice Chair, Asia Harmonization Working Party

Zamane Abdul Rahman, CEO, Medical Device Authority, Ministry of Health, Malaysia

Robert S. Wang, U.S. Senior Official for APEC
 

3:15-5:15pm

Afternoon Session Panel 2
Update on Current Harmonization Activities

Moderator: Dr. Murray Lumpkin, Deputy Director for Regulatory Affairs, Gates Foundation

Panelists: 
Adriana Velazquez Berumen, Senior Adviser and Focal Point for Medical Devices, WHO

Dr. Alexandre Lemgruber, Regional Advisor, Pan American Health Organziation

Dr. Yuka Suzuki, Representative for Harmonization by Doing

Dr. Ruth McNerney, Department Clinical Research, London School of Hygiene & Tropical Medicine

IMDRF Management Committee Meeting (Day 2) - [OPEN ONLY TO MC MEMBERS]
Description:  IMDRF MC members will hold a closed meeting to discuss current issues and future work items.

  • 9:00 a.m. - 5:00 p.m.
  • Lunch for purchase (bag lunch available in meeting room)
  • Agenda managed by US FDA

Friday, September 19, 2014:

Global Harmonization Summit (Day 2) - [OPEN TO ALL REGISTRANTS]
Description: Representatives from regional regulatory harmonization organizations from around the world will discuss current and future regulatory harmonization activities to further worldwide patient access to safe and effective medical technology.

  • 8:30 a.m. - 12:00 p.m.
  • Lunch not provided
  • Agenda developed and managed by AdvaMed

9:00 a.m.

Future of Harmonization
Keynote Address:  Dr. Jeffrey Shuren, IMDRF Management Committee Chair

Moderator: Janet Trunzo, Senior Executive Vice President, AdvaMed

10:15-11:45am

Panel Discussion on Future of Harmonization

Moderator: Janet Trunzo, Senior Executive Vice President, AdvaMed
                                          
Panelists: 
Kimberly Trautman, Associate Director International Affairs, Office of the Center Director, CDRH, FDA

Dr. Mitchell Krucoff, Professor of Medicine, Duke Cardiology
Additional speakers TBC

 

Audience Questions and Feedback

 

11:45 a.m.

Closing Remarks

  Janet Trunzo, Senior Executive Vice President, AdvaMed

12:00 Noon

End of Summit

 

Harmonization by Doing (HBD) West Think Tank Open Meeting - [OPEN TO ALL REGISTRANTS]
Description: HBD is a cooperative effort between Japan and US of academia-industry-government collaboration, prompted by Duke University. This meeting is to discuss the progress of ongoing activities and future direction.

  • 1:00 p.m. - 5:00 p.m.
  • Agenda managed by HBD
US-Japan HBD West 2014 Think Tank Meeting:  HBD Past, Present, Future 
Friday, September 19, 2014
1:00 - 5:15 PM
Embassy Row Hotel, Ambassador Room
Washington, DC
Opening Session I: HBD Past, Present, Future
1:00 – 1:05Welcome
Jeffrey Shuren, MD, JD (U.S. FDA)
1:05 – 1:15Introductions
Neal Fearnot, PhD (Cook Group)
1:15 – 1:30HBD:  Looking At the Second Decade
Mitchell Krucoff, MD (Duke University)
Working Group 1 Report
Moderators:  Gary Thompson (Abbott Vascular) and Madoka Murakami, PhD  (PMDA)
1:30 – 1:40Report of Past Projects:  Educational Think Tanks and POC Clinical Trials
Koji Ikeda, PhD (Tohoku University)
1:40 – 1:50Current and Future Projects:
CLI Small Working Group Report – Nobuhiro Handa, MD (PMDA)
HARMONEE Report – Steve Rowland, PhD (OrbusNeich)
COAST Report – Robert Thatcher (Cardiovascular Systems Inc.)
1:50 – 2:00Moderated Discussion (speakers and audience)
Working Group 2 Report
Moderators:  Kazuhiro Sase, MD, PhD (Juntendo University) and John Laschinger, MD (U.S. FDA)
2:00 – 2:10Report of Past Projects:  Intermacs - JMACS
Kazuhiro Sase, MD, PhD (Juntendo University)
2:10 – 2:20Current and Future Projects:  International TVT Registry and MDEpiNET/PASSION Initiatives
John Laschinger, MD (U.S. FDA)
2:20 – 2:30Moderated Discussion (speakers and audience)
2:30 – 2:45Break
HBD Past, Present, Future:  Integrating Opportunity & Collaboration In A Changing World  
Moderators:  Yuka Suzuki, PhD (PMDA) and Neal Fearnot, PhD (Cook Group)
2:45 – 2:50IMDRF:  What could HBD Add?
Kimberly Trautman (U.S. FDA)
2:50 – 2:55International Regulatory Harmonization:  New Directions in Japan & HBD
Hideyuki Kondo, MBA (MHLW)
2:55 – 3:00IMDRF:  What could HBD Add?
Danica Marinac-Dabic, MD, PhD (U.S. FDA)
3:00 – 3:05Incubators for Novel Medical Devices In Japan & HBD
Fumiaki Ikeno, MD (Stanford University)
3:05 – 3:10What Makes HBD Unique:  U.S. Regulatory View
Bram Zuckerman, MD (U.S. FDA)
3:10 – 3:15What Makes HBD Unique:  Japan Regulatory View
Tomiko Tawaragi (PMDA)
3:15 – 3:20What Makes HBD Unique:  U.S. Industry View
Gary Thompson (Abbott Vascular)
3:20 – 3:25What Makes HBD Unique:  Japan Industry View
Shigetaka Miura (JFMDA)
3:25 – 4:30***Legacy Panel Discussion:  Is Bilateral Effort Useful to Leverage Multi-lateral Regulatory Convergence? ***
Speakers plus David Feigal, Jr., MD, MPH (NDA Partners); Dan Schultz, MD (Greenleaf Health); Susan Alpert, PhD, MD (SFA Consulting); Jeffrey Shuren, MD (U.S. FDA); Toshiyoshi Tominaga , PhD (PMDA); Mitchell Krucoff, MD (Duke University); Janet Trunzo (AdvaMed); Koji Ikeda, PhD (Tohoku University); Jodi Akin (Edwards Lifesciences), Ron Waksman, MD (Washington Hospital Center)
HBD Past, Present, Future:  Japan-USA Regulatory Convergence Efforts
Moderators:  Ken Cavanaugh, PhD (U.S. FDA) and Daisuke Koga, MSc, RPharm (PMDA)
4:30 – 4:40HBD Past, Present, Future: Japan-USA Regulatory Convergence Efforts - US Regulatory View
Jeffrey Shuren, MD (U.S. FDA)
4:40 – 4:50HBD Past, Present, Future: Japan-USA Regulatory Convergence Efforts - Japan Regulatory View
Toshiyoshi Tominaga, PhD (PMDA)
4:50 – 5:00HBD Past, Present, Future: Japan-USA Regulatory Convergence Efforts - Legacy View
David Feigal, Jr., MD, MPH (NDA Partners)
Final Comments and Adjournment
Mitchell Krucoff, MD Duke University)

Registration to Attend DAILY MEETINGS AND EVENTS

Registration is closed as of August 22, 2014. Any questions or concerns should be sent to usa-imdrf-secretariat@fda.hhs.gov. Only confirmed attendees will be admitted to the meetings. There will NOT be on-site registration.

Contact Us

Questions or Concerns about the meeting content: USA-IMDRF-SECRETARIAT@fda.hhs.gov
Special Accommodations or Registration questions: CDRHForum@fda.hhs.gov
For more information about IMDRF: www.imdrf.org

Page Last Updated: 09/15/2014
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