Educational Forum on Medical Device Reporting (MDR), Complaints, and Recalls, Corrections, and Removals

This educational forum intended to provide information about FDA’s medical device regulations to the regulated industry, particularly small businesses. It was held in response to the interest in the topics discussed from small medical device manufacturers.

The goal of the workshop was to present information that will enable manufacturers and regulated industry to better comply with the medical device regulations. The following topics were discussed at the workshop:

  1. Medical Device Reporting (MDR),
  2. The Role of Complaint Files,
  3. Recalls, Corrections, and Removals, and
  4. Corrective and Preventive Actions (CAPA) as it applies to complaints.

Date and Time: Friday, June 15, 2012, from 8 AM to 5 PM [Agenda] [Speakers]

Location: The Grand Ballroom, Third Floor, at The Renaissance Dallas Hotel, 2222 Stemmons Freeway, Dallas, Texas, 75207.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 provided information about ground transportation options.

Continued Education Units (CEU) or Contact Hours: Texas A&M University, Department of Biomedical Engineering, provided 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.

Contact Person: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, Suite 900, Dallas, Texas 75204, phone 214-253-4952, fax 214-253-4970, email david.arvelo@fda.hhs.gov. Or use our Feedback Form.

Registration: The registration fee was used to offset expenses of hosting the event, including the venue, continental breakfast, lunch, break refreshments, materials, and audiovisual equipment. Early registration ended on Friday, June 1, 2012. Regular registration ended on Friday, June 15, 2012, 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 $75 $50

Online registration using Visa, Mastercard, and American Express was available through 123 Signup. Each attendee registered individually using their email address as their unique identifier. Organizations registering multiple individuals with a corporate credit card registered each individual using their name and email address. The corporate cardholder entered their corporate credit card information and an additional email address to receive a copy of the credit card receipt.

As an alternative, some sent 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 accepted registrations onsite on the day of the event beginning at 7:30 AM at the regular registration fee stated in the table above.

Registrants had the ability to modify their registration information and pre-event survey answers online.

Cancellation Policy: Cancelled registrations were subject to a 10% non-refundable cancellation fee if done by no later than May 31, 2012. Registrations were not eligible for cancellation on or after June 1, 2012. Substitutions were possible no additional charge up to and including the day of the event, June 15, 2012.

Special Accommodations: Special accommodations due to a disability were possible with notification to the Contact Person (above) no later than 14 days before the date of the event.

Dress Code: The dress code was business casual.

Food: Continental breakfast, coffee service, mid-morning refreshments, a buffet lunch, and mid-afternoon refreshments were provided with registration.

Materials: Handouts of the presentations are organized in a single Portable Document Format (PDF) file for download: Educational Forum Handouts as of June 11, 2012. This digital document is 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 was a green meeting. We encouraged attendees to bring a digital tablet or notebook computer preloaded with the handouts file.

Press Releases:

  1. March 22, 2012, Text and in PDF
  2. March 26, 2012, Text
  3. May 7, 2012, Federal Register Notice of Public Workshop

Miscellaneous: The Dallas Convention & Visitors Bureau provided valuable coupons and discounts for our attendees:

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