The Insider: Summer 2009
FDA Agent NewsletterIn this Issue:
Vision Expo West Meetings Schedule
The Vision Council Meetings at International Vision Expo West 2009
International Vision Expo West will be held October 1-3, at the Sands Convention Center in Las Vegas. The Vision Council will host several meetings around the show. All meetings will be held at the Venetian unless otherwise noted. Room numbers will be added closer to the event date. We look forward to seeing you there!
Tuesday, September 29
Data Communication Standard/Direct Surfacing Task Force Meeting
1:00 p.m. - 5:00 p.m.
AR Steering Committee Working Lunch
1:00 p.m. - 5:00 p.m.
Wednesday, September 30
Lens Processing & Technology Division Meeting
8:00 a.m. - 10:00 a.m.
Statistics Committee Meeting
10:45 a.m. - 12:15 p.m.
Eyewear & Accessories Division Meeting
12:15 p.m. - 2:45 p.m.
Lens Division Meeting
1:00 p.m. - 2:30 p.m.
The Vision Council Board of Directors
3:00 p.m. - 6:00 p.m.
Thursday, October 1
Public Affairs Committee Meeting
12:00 p.m. - 2:00 p.m.
Better Vision Institute (BVI) Dinner
6:00 p.m. - 8:00 p.m.
Restaurant TBD
Saturday, October 3
Sunglass & Reader Division Reception
6:00 p.m. - 7:30 p.m.
Sunday, October 4
Sunglass & Reader Steering Committee
8:00 a.m. - 10:00 a.m.
Sunglass & Reader Division
10:00 a.m. - 2:00 p.m.
Tradeshow Update
International Vision Expo East Audit
To ensure accurate attendance figures, International Vision Expo conducts a third-party audit after each show. This year, figures from International Vision Expo East show that there was a decrease in attendance by 11 percent compared to 2008. This is slightly ahead of on-site projections, estimated at about 12 percent.
"We are very pleased with our attendance figures for International Vision Expo East," said Tom Loughran, event director for Reed Exhibitions. "We knew that this was going to be a difficult year for the show, but the number of eye care professionals and buyers who attended the show are a testament to the value of International Vision Expo to the optical community."
Buyers (20 percent), optometrists (17 percent) and opticians (14 percent) comprised the largest groups of attendees by job title. The majority of attendees hailed from independent optometric practices (29 percent) followed by independent opticianry chains with one to five locations (12 percent). Additionally, International Vision Expo East welcomed nearly 2,300 international attendees.
"We know that over 80 percent of exhibition attendees have an influence on purchasing decisions at show and 55 percent have buying plans as a result of attending," said Loughran. "For our exhibitors, event marketing is the discipline that best accelerates and deepens engagement with their target audiences."
To learn more about the audit, contact Danielle Fralen, The Vision Council show program coordinator, at dfralen@thevisioncouncil.org or 703-740-0627.
International Optical Fair Tokyo
The Vision Council understands the economic severity and uncertainly associated with these unusual times. It is in these challenging times that organizations should make a concerted effort to expand into new markets of distribution. Exhibiting at the International Optical Fair Tokyo (IOFT) offers the most effective entry into Asia's largest optical market - Japan. The increasing trend for fashion eyewear in Japan has resulted in a boost for eyewear consumption. Many Japanese own more than two pairs of eyeglasses and imports of unique foreign eyewear are on the rise.
IOFT is organized by Reed Exhibitions, who can help you maximize your investment in the show. Reed can provide your company with:
- Pre-show marketing support free of charge
- Turn-key booth options as a cost effective solution for exhibiting internationally
- Local support throughout the exhibiting experience to help prepare you for your trip and overcome cultural barriers
This year's exhibition will take place October 27-29, 2009, at Tokyo Big Sight, Japan. Please visit the IOFT website at www.ioft.jp/english or contact Beth Casson with Reed Exhibitions at bcasson@reedexpo.com or at (203) 840-5308 to learn more about this exciting and unique opportunity.
FURLS Password
Save and Change Your FURLS Password
Recently the U.S. Food and Drug Administration (FDA) sent a notice to all device firms registered with the FDA on the topic of maintaining passwords in the FDA's on-line registration system known as FURLS. Those of you who are responsible for your company's annual registration will remember how important the password and account identification are. Without your password and account ID you cannot access your account information in FURLS, and thus cannot update, change or complete your annual registration obligation.
The FDA's notice explained that the FURLS passwords (NOT the account IDs) are time sensitive and expire every 90 days. This does not mean that you must replace the password every 90 days. What it does means is that because most companies visit the FURLS website only once a year to complete their annual registration it is more than likely that your password will need to be reset. This is not a hard task, but to do so you will need the following information:
Your FURLS account ID
Your current FURLS password
Your secret question - this was required when you first set up your account in FURLS
The answer to your secret question - again, this was created when you set up your account in FURLS
A number of companies who use The Vision Council as their U.S. FDA Agent have recently misplaced their FURLS passwords and/or account IDs and were unable to complete their annual registration without assistance from The Vision Council. In these situations, The Vision Council works with the foreign company and the FDA to get the missing information. However, this takes time, which can prevent a company from completing its annual registration for the following year during the required October through December period.
What can you do? We recommend that you make sure that you have all the required information handy and that you practice changing your password at least once before you are required to re-register for 2010. We also recommend that you document these changes in writing and retain them where your company can retrieve them. We also recommend providing The Vision Council copies of this information, which we will keep in your file.
If you are having problems tracking down this information, changing your password or if you have other questions about the FDA or shipping merchandise into the United States, and you use The Vision Council as your US agent, feel free to contact Rick Van Arnam at rvanarnam@barnesrichardson.com.
Membership Info
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 our 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.
Here are just a few of the many benefits associated with membership:
• Industry Access - Over 300 companies are members of The Vision Council. By joining the council you will have immediate access to key optical industry leaders and decision makers.
• The Vision Council Executive Lounge - As a member of The Vision Council you would have free access to The Vision Council Executive Lounge where we serve our members a complimentary breakfast and lunch each day of the show.
• 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 call Elaine Kennedy, The Vision Council senior manager of membership, at (703)740-1099 or email ekennedy@thevisioncouncil.org.
Testing Lab
NSL Analytical Named Preferred Testing Lab of The Vision Council
During 2008, The Vision Council Membership Oversight Committee recommended that the organization seek a professionally accredited scien¬tific testing laboratory to allow member companies options for testing. After a lengthy search process and several site visits, NSL Analytical has been selected as the preferred testing lab of The Vision Council.
Upon selection as the preferred vendor, NSL staff - under the direction of president Larry Somrack - took several steps to fully understand the types of testing conducted in the optical field. NSL visited a testing facility at Essilor and several production facilities, as well as interviewed multiple member companies. Based on their research, NSL has expanded their testing menu to provide the tests needed for optical manufacturers.
In June, optical veteran, Steve Ross joined NSL Analytical as a manufacturer representative to the optical industry. Ross is the former owner of Midwest Optical Laboratories in Ohio and a past-president of the Optical Laboratories Association.
As a member of The Vision Council, your company receives preferred pricing from NSL for their services. To learn more information about NSL, please contact NSL at (800) 497-6752.
FDA Counsel
What We Do for You
The Vision Council offers years of experience as a U.S. Food and Drug Administration (FDA) Agent in matters of import/export issues, regulatory issues and FDA regulations. As your agent, we are happy assist you with communications with the FDA on matters involving the importation of sunglasses, frames, prescription lenses and readers.
We are also pleased to offer the expertise of our regulatory and customs counsel, Rick Van Arnam, to assist your company with legal matters related to the importation of medical devices and to the various forms and compliance requirements of the FDA.
Unlike other companies, The Vision Council does not charge extra for assistance in establishment registrations or device listings. We also provide our U.S. FDA Agent clients with this quarterly newsletter which contains helpful information about shipping products into the U.S. as well as critical U.S. data.
Should you open additional offices or assume ownership of new companies or factories that would need to designate a U.S. FDA Agent in order to comply with FDA regulations, please keep The Vision Council in mind.
If you are interested in signing up additional companies for this critical value-added service, please contact us at fda@thevisioncouncil.org.
FDA Registration
You are subscribed to receive Registration and Listing information from the U.S. Food & Drug Administration (FDA). The July 2009 update newsletter is now available. This month's newsletter is about the medical device establishment registration user fee, which some firms are required to pay annually.
Manage your FDA Subscriptions:
- Update your preferences or unsubscribe
- Questions about this service? support@govdelivery.com
- Other inquiries? webmail@oc.fda.gov
Contact Info
Contact Information Form
If you have yet to 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.



