Medical Devices

Medical Devices Regulatory Capacity Building Training Program for AHWP, ASEAN, Latin American and Other Medical Devices Regulators, March 27-28, 2014


Preliminary Announcement and Invitation to Attend

Background: The U.S. Department of Commerce and U.S. FDA invite global medical device regulators to participate in a two-day regulatory capacity building training program in collaboration with the World Health Organization (WHO) to take place on March 27-28 in San Francisco on the margins of the International Medical Devices Regulator Forum (IMDRF) March 25 meeting and the March 26 IMDRF stakeholders forum. The draft agenda for this workshop can be found in the Draft Agenda section. Space for workshop participation is limited, so medical devices regulators are encouraged to register through the below e-mail addresses as soon as possible. The workshop will be held in English and translation will not be provided and there will not be a registration fee to participate in this workshop.

Workshop Scope: The workshop’s objectives are to share information of medical devices regulation based upon the Global Harmonization Task Force (GHTF) global model and in sharing information on the U.S. medical device regulatory system, including basic and advanced topics such U.S. registration and listing, device approvals/clearances, as well as Supply Chain Controls, Unique Device Identifiers (UDI), Software review practices and Combination Products.

Participants and Registration:  Anticipated workshop attendees are medical device regulators from APEC, ASEAN, Latin American and other economies.  To register, complete the registration form and e-mail this form to MDregtraining@trade.gov.

Lodging Information: The workshop will take place at the Westin San Francisco, Market Street, 50 Third Street, San Francisco, California, 94103 (tel: 415.974.8719). Information is available regarding lodging near the workshop venue at a special negotiated rate.  Participants will be responsible for their own lodging costs and reservations. See this section for further lodging details.

Contacts:
Mr. Gerry Zapiain, U.S. Department of Commerce, Gerry.Zapiain@trade.gov; 202 482 2410
Ms. Jane Earley, U.S. Department of Commerce, Jane.Earley@trade.gov; 202 482 6241

U.S. Visa Information: Visa requirements to enter the United States can be obtained on the following U.S. State Department website (travel.state.gov/visa/). If a visa invitation letter is required for travelers from your country or economy, please request this letter from the contacts listed above, Gerry Zapiain or Jane Earley, including your arrival and departure date information.

Additional Training Opportunity:  On March 24. 2014 the Medical Device Epidemiology Network (MDEpiNet) Medical Device Epidemiology Network (MDEpiNet), a Public Private Partnership of international medical doctors, medical professional societies, academia, and health care systems involved with medical devices registries responsible for the International Consortium of Orthopedic Registries (ICOR) and the new International Consortium of Cardiovascular Registries (ICCR) will be offering a training/think tank program. Additional details can be found in the Additional Training section.

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Training Registration Form

All workshop participants are required to complete participant registration. Please send the information below in e-mail to MDregtraining@trade.gov, copying Mr. Gerry Zapiain (Gerry.Zapiain@trade.gov) of the U.S. Department of Commerce by February 15, 2014.

  • Full Name (Mr., Mrs., Ms., Dr.)
  • Organization
  • Economy/Country
  • Title
  • Number of Years Experience as a Medical Devices Regulator
  • Email Address
  • Telephone Number
  • Fax Number

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Lodging Information

To accommodate the needs of participants, the Department of Commerce has negotiated a limited special rate of $189 plus tax with the Galleria Park Hotel for the nights of March 26, 27, and 28, 2014.

Please note that these special rates apply for reservations made by February 26. After that date, availability cannot be guaranteed, and prevailing room rates may apply.

Hotel information:

Galleria Park Hotel (three blocks north of Westin Hotel)
191 Sutter Street
San Francisco, California 94104

Reservations can be made at the hotel’s website www.galleriapark.com using the booking code 1403USDEPA, or by calling 800.792.9639 within the United States, or at +1.415.781.3060 for international callers.

After the group reservations expire on the date indicated above, it will be your own responsibility to find suitable arrangements for your stay in San Francisco for the Medical Devices Regulatory Capacity Building Training Program.

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Draft Agenda

Core Course Instructors and moderators:

Mike Flood – Retired Australia TGA and GHTF Member
Tim Ulatowski – Retired US FDA/CDRH and GHTF Member
Nicole Smith – FDA OIP China Office

Additional speakers:

Bakul Patel – US FDA/CDRH Software Expert
Scott Sardeson (Invited) – GHTF Industry Member and ISO TC 210 US Delegate
USFDA ORA Pacific Regional Office or San Francisco District Office Speakers
Adriana Velázquez and/or Irena Prat (Invited) – WHO and IMDRF WHO Management Committee Members

Draft Agenda:

Thursday March 27th

08:00 – Registration
08:30 – 09:00 – Introductions and Logistics
Thursday’s general theme is Pre-market issues

AM Session:

  • Global Medical Device Regulatory Overview – Mike Flood
  • US FDA Medical Devices Registration and Listing – Nicole Smith
  • US FDA Medical Devices 510(k) and PMA Processes – Tim Ulatowski

Lunch – one and half hours to allow participants to go offsite to local vendors

PM Session:

  • Continue FDA Medical Devices 510(k) and PMA Processes – Tim Ulatowski
  • US FDA Regulation of Software – Bakul Patel
  • US FDA Regulation of Combination Products – Scot Sardeson (Invited)
  • US FDA Regulation of Imports and Exports – US FDA ORA (Invited)

Conclude 17:30pm

Day 2 – Friday March 28th

8:30 – 09:00 – Q & As from the previous day’s presentations
Friday’s general theme is Post-market issues

AM Session:

  • Global Overview and Concluding Product Life Cycle to Post Market Topics – Mike Flood
  • Update on the Revisions of ISO 13485 and Preparing to comment on the Draft International Standard (DIS) in Spring 2014 – Scott Sardeson (Invited)
  • US FDA Post Market Surveillance – Tim Ulatowski

Lunch – one and half hours to allow participants to go offsite to local vendors

PM Session:

  • WHO Medical Devices Structural Re-organization, Follow-up to the 2nd Medical Devices WHO Conference and the future of the IVD Prequalification program – Adriana Velázquez and/or Irena Prat (Invited)
  • USFDA and the Office of International Program and Foreign Field Office – Nicole Smith
  • USFDA ORA and Field Operations – US FDA ORA (Invited)

16:00 - Conclusion

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Additional Training Opportunity - March 24, 2013

Medical Device Epidemiology Network (MDEpiNet) Medical Device Epidemiology Network (MDEpiNet)

The Medical Device Epidemiology Network (MDEpiNet), a Public Private Partnership of international medical doctors, medical professional societies, academia, and health care systems involved with medical devices registries responsible for the International Consortium of Orthopedic Registries (ICOR) and the new International Consortium of Cardiovascular Registries (ICCR) will be offering a training/think tank program on Monday, March 24, 2014.  This program will focus on highlighting the regulatory infrastructure and principles that will leverage medical device registries linked with relevant data sources, and harmonized methodological principles (including surveillance, targeted studies, research, and potential application to support premarket applications). The faculty will evaluate the value of integrating the information from disparate data sources (including registries) throughout total product life cycle, highlight issues related to data quality, interoperability and generalizability, illustrate the role of registries in evidence generation for transformative and mature technologies and examine the role of innovative methodologies and registry infrastructure in impacting the speed and quality of medical device innovation. For further information and to attend this separate training, please contact Danica Marinac-Dabic, MD, PhD at Danica.Marinac-Dabic@fda.hhs.gov.

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Page Last Updated: 07/11/2014
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