FDA Medical Device Industry Coalition (FMDIC) Meeting Minutes of April 3, 2009 Face-to-Face Meeting FDA Dallas District Office Dallas, Texas

Transcription

1 FDA Medical Device Industry Coalition (FMDIC) Meeting Minutes of April 3, 2009 Face-to-Face Meeting FDA Dallas District Office Dallas, Texas Members Present: Members Absent: Tom Brinck, TDSHS (Regulatory Co-Chair) Michael Bollinger, AdvaMed (Industry Co-Chair), FDA-SWRO Scott Nichols, FDA-DALDO, FDA-DALDO Jeff Mansell, TDSHS Rebecca Ellis, ASQ BD (alt) Randy Thoma, BioAustin - (by phone) Jo Svochak, CLMA Brian Blankenship, AdvaMed (alt) Audrey Swearingen, RAPS - by phone Al Alonso, RAPS (alt) Ricky Rodriguez, FDA-DALDO Elaine Crosby, FDA-SWRO Steven Juett, ACCE George Maliakal, ACCE (alt) Cheryl Boyce, ASQ BD, Texas A&M University Sub-Committees and Memberships Finance: Devices 101: Event: Publicity/Outreach: Steve Juett Michael Bollinger Steve Juett Beckie Ellis (Chair) Randy Thoma (Asst. Chair) (Venue) (Publicity) Cheryl Boyce (Speakers) (Finance) Steve Juett (Misc. Duties) Members: Al Alonzo, Tom Brinck, Jeff Mansell

2 Agenda Items 1. Opening Meeting - Michael Bollinger opened the meeting and took the minutes of the meeting. 2. Approval/Correction of Previous Minutes: October 10, Minutes approved as written. January 16, Minutes discussed Minutes to be amended to reflect discussion of covering any shortfall for expenses incurred during Devices 1010 in Austin. FMDIC will cover expenses. Minutes approved as amended. 3. Identification of a gate keeper - Sue volunteered to be gate keeper for this meeting 4. Update of Coalition member list - MDMA - No response from Krista on replacements Beckie notified MDMA president ACTION ITEMS Michael Bollinger 1. Contact Krista Oakes for MDMA primary and alternate. 3 attempts made with no response Beckie talked with Krista but she has not taken action o ACTION ITEM: Beckie will follow-up with MDMA Outreach committee will seek a replacement if no response received o Allow 1 quarter for previous member to find a replacement o Allow 1 quarter additional for Outreach committee to replace o No response in 6 months - remove the organization ACTION ITEM: Quality Committee to change the SOP to reflect membership requirements and actions needed 1. Purchase plaque for Krista with $100 cap Ordered and awaiting payment information from Bill 2. Search for venue in Austin for Devices 101 UTA The Commons Center selected 3. Change format for minutes Begin using the abbreviated format for the minutes 1. Seek academic alternate Tabled for the next meeting 2. Contact tax attorney for non-profit status advice Move to the Finance Committee for action

3 1. Research alternate ways to communicate History of communications efforts discussed Free ways to advertise our events presented Linked-In addresses a specific audience Would serve as another forum in addition to 123 SignUp ACTION ITEM: Beckie to work with David to see if Linked-In will work for FMDIC All Members 1. Consider nominations for new co-chairs All Committees 1. Meet and select chair Quality Committee o Randy to initiate first meeting Finance Committee o Michael to initiate a meeting Devices 101 o Al Alonso elected chair Outreach Committee o to chair Event Committee o Beckie Ellis elected chair 2. Report during next meeting All 5 committees to meet and update actions to the group Finance Committee 1. Develop a budget Meet within the next 30 days Discuss contacting tax attorney for non-profit status advice Devices Meet before February 13th to determine details of Austin presentation Presenters selected o David, Bill and Al Proceeding with recommended facility Need someone to present Recall section o Sherrie Krolczyk? Motion to cover any additional expenses up to $1000 over the estimated $4000 approved o Committee to provide a report of expenses Quality Committee 1. Review SOP, Charter and Scholarship SOP 2. Report recommendations at next meeting

4 Financial Report No report available for this meeting New Items - 1. Purchase of 21 CFR Part 820 handouts Motion to purchase up to $2000 with color logo passed Use as handouts for our events 2. Device 101 topics Additional session in Houston requested Device 101 committee to meet again to determine a location for the fall Motion passed to support an addition Devices 101 session this calendar year o Committee asked to communicate as early as possible on the location Suggestion made to go green with the workbook for Device 101 o Attendees to be ed link and pre-print or bring a laptop to view presentations o Devices 101 to resolve and bring report back at the July meeting 3. Election of new co-chairs Two year term served by 1 regulatory and 1 industry representative o Audrey and Steve nominated to represent industry Audrey elected to serve as industry co-chair o Jeff and David nominated to represent regulatory Tie to be decided by ACCE and If tie continues, Dallas DD to break the tie elected to serve as regulatory co-chair Schedule Next Meeting - July 10, 2009 Action Items Beckie Ellis Contact MDMA primary and alternate. Work with on Linked-In as a means of communication Pick-up plaque for Krista Get proposals for venues for the April 2010 event Seek academic alternate Work with Beckie Ellis on Linked-In as a means of communication All Committees Meet and prepare report for next meeting

5 Finance Committee Develop a budget Contact tax attorney Devices 101 Meet to determine details of 2nd session in Houston Quality Committee Review SOP, Charter and Scholarship SOP Report recommendations at next meeting Important Dates July 10, 2009 Before end of 2009 April 2010 Next meeting of FMDIC, FDA District Office, Dallas Devices 101 in Houston Next Educational Forum