Workshop on Medical Device Interoperability: Achieving Safety and Effectiveness

PUBLIC WORKSHOP: Please forward to any Interested Parties

January 25-27, 2010

FDA White Oak Campus
10903 New Hampshire Ave.
Silver Spring, MD 20993

Co-Sponsored by
FDA/CDRH, Continua Health Alliance, and CIMIT

The Food and Drug Administration (FDA), Center for Devices and Radiological Health, in co-sponsorship with Continua Health Alliance and the Center for Integration of Medicine & Innovative Technology (CIMIT) is announcing a public workshop entitled ‘‘Workshop on Medical Device Interoperability: Achieving Safety and Effectiveness.’’ The purpose of the workshop is to facilitate discussion among FDA, industry, academia, professional societies, clinical investigators and other interested parties on issues related to safe and effective interoperable medical devices.

Dates and Times:
The workshop will be held on January 25-26, 2010, from 9 a.m. to 5 p.m. and on January 27, 2010, from 9 a.m. to 12:00 p.m. Participants are encouraged to arrive early to ensure time for parking and security screening before the meeting. Security screening will begin at 8 a.m., and registration will begin at 8:30 a.m. Non-U.S. citizens are subject to additional security screening, and they should register as soon as possible. If you need special accommodations because of a disability, please contact Susana Rosales (Susana.rosales@fda.hhs.gov) at least 7 days before the public workshop.

Location:
The workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993.

Registration:
For a more detailed agenda and to register for the conference please visit the following web site: http://guest.cvent.com/EVENTS/Info/Summary.aspx?e=659d364a-cf61-4faa-b7e5-673cfb8aef0f.

There is a registration fee of $400 USD to attend the workshop to cover the expenses. Attendees must register in advance. In person attendance is limited to 200 participants. There is also an opportunity to attend a webcast at a reduced fee, please see the registration site for further details.

Registration may be limited to achieve balanced participation. Upon registering, you will receive a notice indicating that your registration has been received and is pending confirmation. You will receive an additional email notifying you if your registration was accepted or declined. You may also register to attend the meeting via webcast for a reduced fee.

If you are a student and would like to register for this event, please note that there is a discounted rate of $150 to attend. Please e-mail Events@continuaalliance.org for further information on how to complete registration. Proof of student status is required obtain this rate (copy of student id). Student status applies to undergrad, grad, medical students, residents and fellows.

Accommodations:
A sleeping room block has been set up at the Sheraton Washington North Hotel for attendees. Details are below:

Sheraton Washington North Hotel
4095 Powder Mill Road
Beltsville, MD 20705

Sleeping rooms are priced at $129.00/night (excluding taxes)

Reservations can be made by calling 1800-325-3535. Please be sure to identify yourself with the Medical Device Interoperability Workshop or CHA110 to take advantage of this rate!

Please note the cut-off date for reservations is Friday, January 15th, 2010.

Opening Plenary Speakers:

Charles P. Friedman, PhD., Deputy National Coordinator for Health Information Technology, Office of the Secretary for Health and Human Services

Jeffrey Shuren, MD, JD, Acting Director, FDA/CDRH

Donna-Bea Tillman, PhD, Director, Office of Device Evaluation, FDA/CDRH

Doug Rosendale, D.O. F.A.C.O.S, Veterans Health Administration, Office of Health Information, Joint Interoperability Ventures