Medical Devices

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
Federal Register Notice
Webcast
Transcript
Agenda
Contact Us

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

Transcript for August 28

Agenda

8-9	Industry Check in
9-9:15	Introduction [FDA: Christy Foreman] Goals of Workshop Explain DCD focus and applicability for other divisions
9:15-9:30	Humorous Mini-Debate All changes should be 30-Day Notices [AdvaMed: Mac McKeen] All changes should be Annual Reportable [FDA: Ken Skodacek]
9:30-10:15	Risk 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.)
10:15-10:30	Break
10:30-11:15	Equipment/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
11:15-12	Moves and Relocations Presentations [AdvaMed: Marguerite Eras] Moves and Relocations Presentations [FDA: Bradley Quinn] Panel Discussion/ Audience Questions Panel: Mac McKeen , Melissa Torres, Brad Quinn
12-1	Lunch
1-1:45	Supplier 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
2:15-2:30	Break
2:30-3:15	Best 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
3:15-4:15	Open Panel Discussion Final audience questions Previously submitted questions not addressed in other presentations Panelists: Ken Skodacek, Brad Quinn, Nicole Wolanski, Melissa Torres
4:15-4:30	Wrap 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