• Answers consumer questions and provides information about the manufacturing and distributing of medical devices.
• Enforces rules and regulations for medical device manufacturers and distributors.
• Investigates complaints related to medical devices or refers complaints to the proper regulatory authority.
• Conducts inspections of medical device manufacturers under contract with the U.S. Food and Drug Administration.
• Responds to disasters to ensure that distressed medical devices do not enter or remain in commerce.
• Conducts medical device health fraud investigations.
• Licenses medical device manufacturers and distributors.
  

Medical Device Distributors and Manufacturers Rules

FDA Medical Device Industry Coalition (FMDIC) Presents an Educational Forum on MDR, Complaints, and Recalls, Corrections, and Removals

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

The goal of the workshop is to present information that will enable manufacturers and regulated industry to better comply with the medical device regulations. The following topics will be 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 coming soon)

Location: The Ellipse Ballroom, Second Floor, at The Renaissance Dallas Hotel, 2222 Stemmons Freeway, Dallas, Texas, 75207. You can make room reservations online or by calling 214-631-2222 and requesting the ‘fmdfmda’ special group room rate. This special group room rate will last until the block of rooms is exhausted. [Directions]

Continued Education Units (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 will contain the number of contact hours. You must complete and turn in the CEU request form before you leave on the day of the event.

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 will be used to offset expenses of hosting the event, including the venue, continental breakfast, lunch, break refreshments, materials, and audiovisual equipment. Early registration ends on Friday, June 1, 2012. Regular registration ends on Friday, June 15, 2012, the day of this event. Note that in the past the registration has filled up and closed well before the day of the event. We recommend you register early.

Register online using Visa, Mastercard, or American Express and secure your seat right now. Note that each attendee must register individually online using their email address as their unique identifier.

If your organization is going to register multiple individuals and pay with an corporate credit card, please register each individual using their name and email address. The corporate cardholder will have an opportunity to enter their corporate credit card information and an additional email address to receive a copy of the credit card receipt.

As an alternative, you may send 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.

After registering, you can modify your registration information online. You can also change your pre-event survey answers online.

If you have any questions about registration, please contact David Arvelo (see Contact Person above).

Registration on site will be accepted on a space available basis on the day of the event beginning at 7:30 AM.

Cancellation Policy: Registrations may be cancelled subject to a 10% non-refundable cancellation fee if done by no later than May 31, 2012. Registrations will not be cancelled on or after June 1, 2012. Substitutions may be made at no additional charge up to and including the day of the event, June 15, 2012.

Special Accommodations: If you require special accommodations due to a disability, please contact David Arvelo (see Contact Person above) no later than 21 days before the date of the event.

Dress Code: The dress code is business casual. We recommend you dress in layers for your comfort.

Food: Continental breakfast, coffee service, mid-morning refreshments, a buffet lunch, and mid-afternoon refreshments are included with your paid registration.

Materials: Handouts of the presentations will be provided to registrants before the event in a single Portable Document Format (PDF) file for download. This digital document will be available to everyone for download after the event at no charge. This is a green meeting. We encourage you to bring your digital tablet computer or notebook computer preloaded with the handouts file. We will not have hardcopy handouts on the day of the event. However, you are welcome to print the handouts file if you wish to bring a paper copy with you. We will have notepads, pens, evaluation forms, and CEU request forms available.

For more information concerning this event, visit the FMDIC website at http://fmdic.org.