Educational Forum
Medical Devices – The Case for Quality
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with the FDA Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public workshop entitled “Medical Devices – the Case for Quality.” The educational forum is intended to seek input from representatives of medical device manufacturers and other stakeholders, on best practices, what has worked for them and what FDA can do to inspire quality efforts. This event will also focus on various topics of interest for those industry representatives who are responsible for insuring compliance with FDA regulations.
Date and Time: The meeting will be held on April 11, 2014 from 8 a.m. to 5 p.m. [Agenda]
Location: The meeting will be held at Wyndham Dallas Suites – Park Central, 7800 Alpha Road, Dallas, TX 75240. Directions and lodging information are available at the FMDIC, Inc. website at http://www.fmdic.org/.
- Direct to Wyndham Dallas Suites – Park Central – 972-233-7600 (choose option 2), please reference group code “04106822FD”.
- Wyndham Worldwide Reservations – 1-800-996-3426. Your attendees must identify themselves as part of the FDA/Medical Device Industry Coalition (FMDIC), Inc. Reference the group code “04106822FD” to receive the Group rate.
- Hotel Website – http://www.wyndham.com/hotels/46502, click on the “Reservations” button and enter arrival and departure information. Click on “Special Rates and Codes” and in the Group Code field, enter “04106822FD” and click “Enter.” Once the code has been entered, select the “Find It” button, and all the available rates will display.
Contact: C. Sue Thomason, CGMP, Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, phone: 214-253-5203, FAX: 214-253-5318, email: sue.thomason@fda.hhs.gov. Or use our Feedback Form.
Transportation: You can fly into Dallas Love Field Airport (DAL, 5 miles away) or the Dallas/Fort Worth International Airport (DFW, 15 miles away). The websites for each airport provide information about ground transportation options.
Continued Education Unites (CEU) or Contact Hours: Texas A&M University, Department of Biomedical Engineering, will provide attendees with the opportunity to obtain certification of attendance upon request on the day of the event. These certificates contain the number of contact hours.
Registration: The registration fee is used to offset expenses of hosting the event, including the venue, continental breakfast, lunch, break refreshments, materials, and audiovisual equipment. Early registration will end on Tuesday, March 11, 2014. Regular registration ends on Friday, April 11, 2014, the day of this event.
| Registration Type | Early Registration Fee | Regular Registration Fee |
|---|---|---|
| General | $250 | $300 |
| Government with ID | $150 | $200 |
| Student with ID | $50 | $50 |
Online registration using Visa, Mastercard, and American Express is available through 123 Signup. Each attendee registers individually using their email address as their unique identifier. Organizations registering multiple individuals with a corporate credit card register each individual using their name and email address. The corporate cardholder enters their corporate credit card information and an additional email address to receive a copy of the credit card receipt.
As an alternative, some send their registration information including the registrant’s name, title, organization, address, telephone and fax numbers, and email address (for each registrant), along with a check or money order (covering all registration fees) payable to the ‘FMDIC, Inc.’, to FMDIC Registrar, 4447 N Central Expressway, Suite 110 PMB197, Dallas, Texas 75205. FMDIC accepts registrations onsite on the day of the event beginning at 7:30 AM at the regular registration fee stated in the table above.
Registrants will have the ability to modify their registration information and pre-event survey answers online.
Cancellation Policy: Cancelled registrations are subject to a 10% non-refundable cancellation fee if done no later than April 1, 2014. Registrations are not eligible for cancellation on or after April 1, 2014. Substitutions are possible at no additional charge up to and including the day of the event, April 11, 2014.
Special Accommodations: Special accommodations due to a disability are possible with notification to the Contact Person (above) no later than 14 days before the date of the event.
Dress Code: The dress code is business casual.
Food: Continental breakfast, coffee service, a buffet lunch, and mid-afternoon refreshments are provided.
Materials: Handouts of the presentations are organized in Portable Document Format (PDF) files for download:
- Safety and Performance Grading of QS Non-conformities
- Medical Device Single Audit Program
- Silverman FMDIC Presentation
- Data Transparency and Quality Metrics
- Medical Device Recall Report
These digital documents are available to everyone for download at no charge. If your computer does not have a PDF reader, you may wish to install the Adobe Acrobat Reader, a free download. This is a green meeting. We encourage attendees to bring a digital tablet or notebook computer preloaded with the handouts file.
During the workshop and as part of a discussion group at each table, participants will be able to provide the FDA feedback to the following questions: Questions for Consideration. A presentation from each table will be followed by a question and answer session.
Press Releases:
- February 19, 2014, Federal Register Notice of Public Workshop
Miscellaneous: The Dallas Convention & Visitors Bureau provided valuable coupons and discounts for our attendees:
