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U.S. Department of Health and Human Services

Medical Devices

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Medical Devices Technology Innovation Partnership (MD-TIP) Workshop, October 26, 2010

Department of Health and Human Services
U.S. Food & Drug Administration (FDA)
and The Rector and Visitors of the University of Virginia (UVA )
present a co-sponsored
Medical Devices Technology Innovation Partnership (MD-TIP) Workshop
FDA White Oak Campus Building 31
Silver Spring, Maryland

Tuesday October 26, 2010

Title: "Innovation, Technology Transfer and Scientific Interchange: Leveraging Academic and FDA Collaborations to Resolve Unmet Public Health Needs"

Registration is now closed as of October 15. On-site registration WILL NOT be permitted for security reasons.

Updated Oct. 4, 2010: Added logistics page for FDA White Oak Campus.


Description

The Food and Drug Administration (FDA) is hosting its first Medical Devices Technology Innovation Partnership (MD-TIP) Project effort via a one day workshop. This effort is being co-sponsored by The University of Virginia (UVA). Other universities involved in planning the event and developing the concepts for this effort have been: Howard University, Johns Hopkins University, University of Maryland at College Park, University of Maryland, Baltimore and the University of Pennsylvania.

The health care challenges of the 21st century require innovative solutions through collaboration between Federal agencies and academia. This workshop will encourage increased collaboration between FDA and academia in the area of innovative medical device discovery and development. Participants will learn key, practical information on FDA and CDRH initiatives such as the Critical Path Initiative, Public Private Partnerships, fellowship opportunities, technology transfer, inventions and other topics. Special breakout sessions will provide in depth information on topics such as: FDA regulatory processes, technological innovations in spinal diseases, home healthcare and the artificial pancreas. The conference will conclude with a general session entitled: "Real World Examples and Experiences." The meeting is a pilot effort targeting universities in the Mid-Atlantic region. This event will brings together experts involved in medical device regulation, scientific research and exploration and technology transfer processes and strategies in order to learn and share information regarding opportunities, obstacles, best practices and challenges. Representatives from the federal government and academia will be attending and presenting at this interactive meeting.

Date, Time and Location

This workshop will be held on Tuesday October 26, 2010, from 7:30am to 5pm, at

Food and Drug Administration
10903 New Hampshire Avenue, Building 31
FDA Conference Great Room
Silver Spring, MD 20993

Registration and Security Clearance Processes will take place from 7:30 to 8:30am. Presentations will start promptly at 8:30am and the meeting will end at 5:00pm.

Tentative Outline of the Agenda and Workshop Schedule

8:30 - 9:00am Keynote Address; FDA /CDRH Overview; Science Task Force
9:15am - 12:00pm

Key Agency Efforts and Leveraging Initiatives
Critical Path
Public Private Partnerships

Fellowships and Internships program

12:00 - 1:00pm Working Lunch
1:30 - 3:00pm Concurrent Breakout Sessions (6 sessions, 3 per Group)
Group 1: Education
“A Primer on 510(k)s and PMAs”- A review of the processes for submission of device 510(k)s and Premarket Applications (PMAs) will be covered in this session.

“A Primer on IDEs, Clinical Trial Design and Interface with IRBs”- This session will cover a review of the processes for submission of Investigational Device Exemptions (IDEs), clinical trial design practices and how these topics interface with regulations governing the protection of human research subjects.

“Linking Commercialization to the Research Process: How Do We Handle Gaps”- This panel will comprehensively look at the connection between good scientific research practices, the basic requirements for data supporting regulatory submissions and commercial risk reduction.

Group 2: Innovative Frontiers - These topics will be covered using an interactive and didactic format with panelists from academic research, government research and regulatory areas in addition to government and academic administrators.

“Artificial Pancreas”
“Home Health Care”
“Spinal Disease”

3:30 - 4:30pm Real World Examples/Experiences
4:30 - 5:00pm Closing Remarks and Next Steps

Registration Information

Registration is closed as of October 15, 2010.

There is no fee to register for the workshop. Registration was on a first-come, first-served basis.

If you need special accommodations due to a disability, please contact Sophia Smith at 301-796-5420, at sophia.smith@fda.hhs.gov at least 7 days in advance of the meeting.

Contacts for Additional Information

For information regarding logistics, registration and special accommodations, contact:

  • Sophia Smith
    Office of Center Director
    Center for Devices and Radiological Health
    Food and Drug Administration
    10903 New Hampshire Avenue, Bldg. 66
    Silver Spring, MD 20993
    phone: 301-796-5420
    email: Sophia.Smith@fda.hhs.gov

For information regarding the program, contact:

  • David Chen
    Director of Translational Research, UVA
    phone: 434-243-7357
    email: davidchen@virginia.edu
  • Kwame Ulmer
    Deputy Director- Science and Policy
    Division of Anesthesiology, General Hospital, Infection Control & Dental Devices
    Office of Device Evaluation
    Center for Devices and Radiological Health
    Food and Drug Administration
    phone: 301-796-6471
    email: Kwame.Ulmer@fda.hhs.gov
  • Francis Kalush, Ph.D.
    Diagnostics & Personalized Medicine Network Leader
    Office of the Center Director
    phone: 240-205-9704
    email: Francis.Kalush@fda.hhs.gov