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The Insider: July 2010

FDA Agent Newsletter

Device Listings

Contact Information Form

International Vision Expo News

Meetings at International Vision Expo West

ISO Sponsorship Opportunities

Join The Vision Council

 

Device Listings
Manufacturers of medical devices are required to file separate device listings for each medical device that they produce, including sunglasses, readers, lenses and frames. If you add a product to your line that does not qualify for the medical device listing you have, you will need to add it through the FDA.

To list a new medical device with the FDA, you will need to log into the FDA's Electronic Registration and Listing System (FURLS) with your account ID and password. From there, you will access the "Create Listings for Medical Devices" section. After listing your new device, you should receive your device listing number shortly thereafter from the FDA.

For your information the following are the product codes of the above medical devices:

Classification: Spectacle, magnifying Product Code: HOI
Classification: Frame, spectacle Product Code: HQZ
Classification: Sunglasses, (non-prescription, including photosensitive) Product Code: HQY
Classification: Prescription, Spectacle Lens Product Code: HQG

Please note that the device listing number for each product exported to the United States needs to be referenced on all shipping invoices in addition to your registration number. We have found from past experience that many shipments held up upon arrival are for the lack of medical device numbers on the invoices.

 

Contact Information Form
As a reminder, if you did not return your Contact Information Form, please send it to us as soon as possible with any corrections to your company's address, phone, fax or email information. It is vital that we have the most up-to-date information on your company, should we need to contact you. If you need another copy of the form to review, please contact Swea Nightingale at sweanight@earthlink.net.

 

International Vision Expo News
The Vision Council and International Vision Expo have several programs in place to help exhibitors make the most of their tradeshow investment.

We invite you to join us in Boston, Massachusetts to attend TS2: Total Solutions Marketing for the Exhibit and Event Professional. This 3-day exhibitor education event, taking place July 13-15, is designed for both seasoned tradeshow managers wanting to take their exhibiting results higher and tradeshow novices who want to get up to speed fast. Through our partnership, we have negotiated a significant discount on your company's registration to attend TS2. For more information on this exceptional education opportunity, please click here.

The Sales Pro Incentive Program is now live on the International Vision Expo West website. This FREE program allows you to register all your customers to the show with FREE admission to the exhibit hall (subject to the Show's attendee eligibility rules). This exciting opportunity not only allows you to promote your products and drive additional traffic to your booth, but you can also earn up to $40 per new attendee you sign up.

If you prefer more of a company-wide effort, the International Vision Expo Customer Invitation Program is available to exhibitors. This program allows you to communicate your presence at International Vision Expo, increase your booth traffic and register your customers and prospects for FREE to the exhibit hall! The Customer Invitations include:

NEW for 2010 - We've upgraded our Show Specials program to bring your company even more exposure to International Vision Expo West attendees. When you submit your special, not only will it continue to be featured on the International Vision Expo West website, but several other FREE marketing vehicles. We are also collecting a "what's new" show special of your company and products - anything from new licenses, research findings, technological advances, etc, that your company is looking to promote at this time.

Visit the International Vision Expo West website for more information on these free opportunities.

 

Meetings at International Vision Expo West
The Vision Council will host a series of meetings at International Vision Expo West. The meetings schedule is below.

All meetings will be held at The Venetian and the Sands Expo and Convention Center between October 5th and the 10th. For more information, please contact Amber Robinson at arobinson@thevisioncouncil.org.

Date Time Event/Meeting
Tuesday, October 5th, 2010 8:00am-12:00pm Data Communication Standard Unified
  1:00pm-5:00pm Country of Origin for Lenses
  1:00pm-5:00pm Sustainability Task Force
  1:00pm-5:00pm Lens Bevel Task Force
  6:30pm-10:30pm AR Steering Committee Dinner
Wednesday, October 6th, 2010 9:30am-11:00am Lens Division
  11:00am-12:30pm Statistics Committee
  12:30pm-3:00pm Eyewear & Accessories Division
  1:00pm-3:00pm Lens Processing Technology Division
  1:00pm-5:00pm Lens Technical Committee
  3:00pm-6:00pm The Vision Council Board of Directors
  6:30pm-10:30pm Mass Lens Manufacturers Dinner
Saturday, October 9th, 2010 6:00pm Sunglass & Reader Division Reception
Sunday, October 10th, 2010 8:00am-10:00am Sunglass & Reader Division Steering Committee
  10:00am-2:00pm Sunglass & Reader Division

 

ISO Sponsorship Opportunities
The Z80 standards committee and its administrator, The Vision Council, are pleased to host the 2010 International Standards Organization (ISO) meeting in Las Vegas just prior to International Vision Expo West.

ISO is the world's largest developer and publisher of international standards. ISO standards focus on the development, manufacturing and the supply of products and services. The ISO SC 7 Ophthalmic Optics meeting occurs once every 18 months and is a working meeting that attracts the leading technical experts from around the world. As you know the standards process serves as the critical foundation for everyone in the optical community.

In order to make this a first-class affair we need your assistance. Becoming a sponsor allows you to support 140 leading technical experts from around the world who set the ISO standards for the products you sell. We have established a variety of sponsorship opportunities allowing you to display your commitment to the international standard development process. For more information, please contact Amber Robinson at arobinson@thevisioncouncil.org.

 

Join The Vision Council
Membership in The Vision Council makes you a part of the only organization of its kind, one that works every day on behalf of its members and the entire ophthalmic community to grow the optical marketplace. As a member of The Vision Council, you'll be part of a committed, results-driven organization that is strengthening the entire industry.

Listed below are just a few of the many benefits associated with membership:

If you would like any additional information or have any questions please contact Greg Chavez, The Vision Council vice president of member services, at (703) 740-1099 or gchavez@thevisioncouncil.org

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