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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - Division of Cardiovascular (DCD) 30-Day Notices and Annual Reports Workshop, August 28, 2012

The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Division of Cardiovascular Devices (DCD) 30-Day Notice and Annual Report." This workshop will be co-sponsored with Advanced Medical Technology Association (AdvaMed). The purpose of this workshop was to discuss details of the reporting requirements for both 30-Day Notices and Annual Reports for cardiovascular devices.

Date, Time and Location

This workshop was held August 28, 2012, beginning at 8:00 am – 5:00 pm at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center (Great Room, Sections B&C)
Silver Spring, MD 20993

Webcast

Transcript

Agenda

8-9Industry Check in
9-9:15

Introduction [FDA: Christy Foreman]

  • Goals of Workshop
  • Explain DCD focus and applicability for other divisions
9:15-9:30Humorous Mini-Debate
  • All changes should be 30-Day Notices [AdvaMed: Mac McKeen]
  • All changes should be Annual Reportable [FDA: Ken Skodacek]
9:30-10:15Risk Assessment Role in Evaluating Change [FDA: Lindsay Pack]
Risk Assessment Role in Evaluating Change [AdvaMed: Tony Blank]
Panel Discussion/ Audience Questions
Panel: Kathy Vittum; Richard Dujmovic, Erin Keith, Melissa Burns
(Panel members also include speakers for each topic.)
10:15-10:30Break
10:30-11:15Equipment/Software Changes Presentation [AdvaMed: Melanie Raska]
Equipment/Software Changes Presentation [FDA: Melissa Burns]
Panel Discussion/ Audience Questions
Panel: Kanu Vadodaria; Robert Bach, Linda Ricci, Shawn Forrest
11:15-12Moves and Relocations Presentations [AdvaMed: Marguerite Eras]
Moves and Relocations Presentations [FDA: Bradley Quinn]
Panel Discussion/ Audience Questions
Panel: Mac McKeen , Melissa Torres, Brad Quinn
12-1Lunch
1-1:45Supplier Changes Presentations [AdvaMed: Lisa Wells]
Supplier Changes Presentations [FDA: Melissa Torres]
Panel Discussion/ Audience Questions
Panel: Alicia Hemphill; Jacque Keller, Brad Quinn
1:45-2:15

Submission Types and Conversions [FDA: Erin Keith]
Panel Discussion/Audience Questions

  • What’s not appropriate for an AR or 30 Day
  • AR to 30-Day
  • AR to RTR
  • 30-Day to 135-Day
  • Panel: Nicole Wolanski, Wanda Sawyer-Major
2:15-2:30Break
2:30-3:15Best Practices for submissions [FDA: William MacFarland, Mark Fellman, Lindsay Pack]
Panel Discussion/ Audience Questions
  • Annual Report Format and Content
  • Annual Report CRM Example
  • 30-Day Notice Format and Content
  • Panel: Ken Skodacek, Nicole Wolanski, Janet Benson
3:15-4:15Open Panel Discussion
4:15-4:30Wrap Up
  • Next Steps
  • Creative Ideas for Improvement

Contact Us

For questions regarding workshop content please contact:

Lindsay K. Pack
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., WO-66, Rm. 1260
Silver Spring, MD 20993
301-796-5214
email: Lindsay.pack@fda.hhs.gov