The Food and Drug Administration (FDA) is holding a public workshop to share FDA’s understanding of the risks and benefits of external defibrillators, to clarify FDA’s current expectations for how industry should identify, report, and take action on problems observed with these devices, and to promote innovation for next-generation devices that will bring safer, more effective external defibrillators to market.
- Date, Time and Location
- Agenda
- Registration
- Contact Us
Date, Time and Location
This meeting will be held December 15, 2010, from 8:00 a.m. to 5:30 p.m., and December 16, 2010, from 8:00 a.m. to 12:00 p.m.
The public workshop will be held in the Great Room at the Food and Drug Administration, White Oak Campus, Bldg. WO-31, 10903 New Hampshire Ave., Silver Spring, MD 20993.
The meeting will be webcasted.
Tentative Agenda (Subject to Change)
December 15
December 16
Registration to Attend the Workshop
If you wish to attend this workshop, you must register by close of business on November 29, 2010.
There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you wish to make an oral presentation during any of the open comment sessions at the meeting, you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the agenda from this meeting. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation to [email protected]. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.
If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at [email protected] at least 7 days in advance of the meeting.
[email protected]
- Victoria Wagman
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: 301-796-6581
email: [email protected]
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: 301-796-6581
email: [email protected]
For information regarding the program, contact:
- Charles Zimliki, Ph.D.
Chair, Critical Path InterAgency Artificial Pancreas Working Groups
Division of Anesthesiology, General Hospital, Infection Control Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration
phone: 301-796-6297
email: [email protected]
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