The Insider: July 2010
FDA Agent NewsletterInternational Vision Expo News
Meetings at International Vision Expo West
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:
- An animated web banner with custom URL promoting free exhibit hall admission that you can post on your company's website, as well as include in emails, email signatures and newsletters.
- A customizable electronic invitation highlighting your company's booth and product description
- A printed registration form available for exhibitors to print and distribute to their customers and patients.
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:
- Industry Access: Over 300 companies are members of The Vision Council. By joining you will have immediate access to key optical industry leaders and decision makers.
- Valuable Optical Marketplace Information: The Vision Council members receive timely optical marketplace reports providing your organization with a real advantage in the optical industry. The Vision Council is your one source for invaluable optical market data and trends.
- Volunteer Leadership: Help set the direction for the industry by participating in one of The Vision Council's committees, subcommittees or taskforces.
- Technical Information: The Vision Council is actively creating and implementing standards at the industry, national and international levels. As a member of The Vision Council, you will have access to the latest industry technical and standard information.
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.



