Medical Devices

Public Workshop - Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI), February 2, 2017

The Food and Drug Administration (FDA), is announcing the following public workshop entitled "Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI).” The purpose of the public workshop is to obtain stakeholders' input on the coordination of registries for Devices Used for Acute Ischemic Stroke Intervention. FDA is soliciting input on all aspects of the workshop topics which include: Clinical Common Data Elements, Standardized Definitions, Case Report Forms, Informatics, Sustainability, Data Quality, and additional scientific, methodological, and clinical considerations for evaluating information obtained from registries. A discussion paper including background information and potential topics for discussion will be posted on this web page prior to the workshop.


Date, Time and Location

This meeting will be held February 2, 2017, beginning at 8:00 am – 5:00 pm at the following location:

National Institutes of Health (NIH) Campus
9000 Rockville Pike
Ruth L. Kirschstein Auditorium
Natcher Conference Center, Bldg. 45
Bethesda, MD, 20892
The entrance for the public workshop participants (non-NIH employees) is through the NIH Gateway Center located adjacent to the Medical Center Metro, where routine security check procedures will be performed.

NIH Campus Information

Webcast

Due to the nature of this public meeting, there will be no webcast or transcription service.  

Agenda

Time

Subject

7:30 - 8:00 AM

Registration

8:00 - 8:10 AM

Welcome & Introductions [Carlos Peña, Ph.D., M.S. (FDA)]

8:10 - 8:30 AM

FDA’s National Evaluation System for Health Technology (NEST) [Danica Marinac-Dabic, MD, PhD (FDA)]

8:30 - 9:30 AM     

Vascular Quality Initiative (VQI) Registry Example: What is the Value Proposition?

  • FDA Perspective [Jose Pablo Morales, MD (FDA)]
  • Industry/Society [Jack Cronenwett, MD (Dartmouth-Hitchcock Medical Center)]
  • Responder [Art Sedrakyan, MD, PhD (Weill Cornell Medical College)]
  • Questions
9:30 - 9:50 AMIntroduction to Data Use Agreements [Benjamin Eloff, PhD (FDA)]

9:50 - 10:10 AM

Break

10:10 - 10:30 AM

Introduction of Working Groups [William Heetderks, MD, PhD (FDA)]

  • Clinical
  • Informatics and Methodology
  • Sustainability and Value
10:30 - 12:00 PMBreakout Session I

12:00 - 1:00 PM

Lunch (on your own)

1:00 - 2:30 PM

Breakout Session II

2:30 - 2:45 PM

Break

2:45 - 4:00 PM

Working Group Summaries and Group Feedback

4:00 - 4:30 PMBreakout Session III (Integrate Group Feedback and Establish Next Steps)

4:30 - 5:00 PM

Report Next Steps and Closing Remarks

Documents

Registration to Attend the Workshop

Online registration is closed.

There will be on site registration tomorrow morning, Feb. 2nd at 7:30 am.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Peggy Roney, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5671, peggy.roney@fda.hhs.gov.

Contact Us

For questions regarding workshop content please contact: Jamie Waterhouse, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, rm. 2611, Silver Spring, MD 20993, 301-796-3063, email: Jamie.Waterhouse@fda.hhs.gov.

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