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 [1]
- Agenda [2]
- Registration [3]
- Contact Us [4]
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
| Time | Session Title | Speaker |
|---|---|---|
| 8:00 a.m. | Meeting begins | |
| Opening Remarks | Megan Moynahan, Network Leader, Cardiac Electrophysiology Devices Network | |
| FDA Keynote Speaker | William Maisel, CDRH Deputy for Science | |
| 8:30 a.m. | Topic #1: Quality Systems Practices for External Defibrillator Manufacturers | Moderator: Kim Trautman, Office of Compliance |
| FDA Presentation | Melissa Torres, Office of Compliance | |
| Additional Presentation(s) | TBD | |
| 9:15 a.m. | Open Discussion for Topic #1 | |
| 11:15 a.m. | Topic #2: Engineering Design Practices for External Defibrillator Manufacturers | Moderator: Mitchell Shein, Office of Device Evaluation |
| FDA Presentation | Alford Taylor, Office of Science and Engineering Laboratories | |
| FDA Presentation | Charles Ho, Office of Device Evaluation | |
| Additional Presentation(s) | TBD | |
| 12:00 | LUNCH BREAK | |
| 1:15 | Open Discussion for Topic #2 | |
| 3:15 | Topic #3: Clinical Practices and User Needs | Moderator: Oscar Tovar, Office of Device Evaluation |
| FDA Presentation | Tosia Hazlett, Office of Surveillance and Biometrics | |
| Additional Presentation(s) | TBD | |
| 3:45 | Open Discussion for Topic #3 | |
| 5:30 | Meeting Adjourn |
December 16
| Time | Session Title | Speaker |
|---|---|---|
| 8:00 a.m. | Meeting begins | |
| Opening Remarks | Megan Moynahan, Network Leader, Cardiac Electrophysiology Devices Network | |
| Keynote Speaker 1 | Jonathan Sackner-Bernstein Associate Directory for Technology and Innovation | |
| Keynote Speaker 2 | TBD | |
| 8:30 a.m. | Topic #4: Innovation and Future Direction for External Defibrillators | Co-Moderators: Jonathan Sackner-Bernstein, Megan Moynahan |
| FDA Presentation | Veronica Sansing, Office of Surveillance and Biometrics | |
| Additional Presentation(s) | TBD | |
| 9:30 a.m. | Open Discussion for Topic #4 | |
| 11:30 a.m. | Closing Remarks | Megan Moynahan |
| Noon | Meeting Adjourn |
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 megan.moynahan@fda.hhs.gov [5]. 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 susan.monahan@fda.hhs.gov [6] at least 7 days in advance of the meeting.
Contacts for Additional Information
For information regarding logistics, registration and special accommodations, contact:
- Susan Monahan
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, Bldg. 66
Silver Spring, MD 20993
phone: 301-796-5661
email: Susan.Monahan@fda.hhs.gov [7]
- 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: Victoria.Wagman@fda.hhs.gov [8]
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: Charles.Zimliki@fda.hhs.gov [9]
SOURCE [10]
