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FDA Public Workshop on External Defibrillators, December 15-16, 2010

Mon, 11/15/2010 - 4:30am

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

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 . 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 at least 7 days in advance of the meeting.

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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

  • 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

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

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