Information For Consumers

Information For Eye Care Professionals

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The Insider: March 2010

FDA Device Registration and Listing Reminder

If You Need to Designate a U.S. Agent for a New Company or Factory

International Vision Expo Updates

The Vision Council Meeting Schedule for International Vision Expo East

Join The Vision Council

FDA Device Registration and Listing Reminder
If your company has not yet renewed its 2010 registration, you will need to do so as soon as possible if you intend to ship product into the United States this year. If your listing is deleted by the FDA for non-renewal and payment of the fee, and later you wish to export product into the United States, you will need to register as a new account.

Please note: You need to pay the fee for the registration first in the DFUF website. You receive a PIN number (Payment Identification Number). You will also need to retrieve the PCN number (Payment Confirmation Number) once your payment is confirmed by the FDA. Once you have these two numbers you can then go to FURLS to complete your registration.

For additional information and links, please go directly to their site.
If you encounter problems in renewing your registration, please do not hesitate to contact us for assistance at fda@thevisioncouncil.org.

If You Need to Designate a U.S. Agent for a New Company or Factory
There are many advantages to using The Vision Council as the U.S. Designated Agent to comply with FDA regulations:

• We assist you with communications with the FDA on matters involving the importation of sunglasses, frames, prescription lenses, and readers.

• We offer years of experience as a U.S. Designated Agent and in matters of import/export issues, regulatory issues and FDA regulations. This includes the expertise of regulatory and customs counsel, Rick Van Arnam, to assist your company with matters related to the importation of medical devices and to the various forms and compliance requirements of the FDA.

• The Vision Council does not charge extra for assistance in helping with establishment registrations or device listings.

• FDA U.S. clients receive a quarterly newsletter containing helpful information about shipping products into the United States as well as critical U.S. data.

If you are interested in signing up an additional company for this critical value-added service, please contact us at fda@thevisioncouncil.org.

International Vision Expo Updates
A Show Committee meeting took place January 28, during the Executive Summit that reviewed several issues regarding International Vision Expo. Topics included International Vision Expo East 2010, International Vision Expo West future dates, OLA effect and Javits construction information.
• International Vision Expo East 2010 will exceed budget in net square footage and will likely hit its budget for sponsorship revenue. Pre-registration to date is also on par with 2009. The Vision Council's budget is based on the show's budget so exceeding expectations in these revenue streams is great news for the organization.

• Many new programs will be unveiled at International Vision Expo East 2010, including hosted buyer and international VIP program, website redesign built around areas of interest, expanded show specials program focusing on what's new, Map Your Show locator and appointment setting system and a series of video projects. Plus, we will bring back popular keynotes and launch Shamrock Fest with a special young OD networking element.

• A large part of the OLA merger talks focus on the ability to co-locate their annual meeting at International Vision Expo West, possibly beginning in 2010. Jamie Shyer, Deb Castor, Steve Sutherlin and Bob Dziuban are the task force members assigned to address the co-location and have been working towards a successful co-location at this year's International Vision Expo West show.

• International Vision Expo show management announced that they will change the dates for International Vision Expo West 2011 to September 22-24, 2011. The original dates were September 8-10, 2011. This change was made as attendee and exhibitor research indicates that the middle to end of September is the optimal time to hold the trade show and conference.

• The Javits Convention Center will undergo a renovation and expansion this year after International Vision Expo. The roof, windows, HVAC and building systems will be replaced. This construction will affect the Crystal Palace and different areas of the show floor depending on which construction phase the center is in during each show, beginning in 2011 and ending in 2014. The Show Committee will continue to review the situation and make recommendations to ensure the best satisfaction levels for both attendees and exhibitors each year.

Please contact Angela Pendergrass, The Vision Council director of shows, at apendergrass@thevisioncouncil.org with any questions.

The Vision Council Meeting Schedule for International Vision Expo East
The Vision Council will host a series of meetings at International Vision Expo East. The meetings schedule is below. All meetings will be held in the Westin NY hotel with the exception of the AR Steering Committee Dinner and Sunglass and Reader Division Dinners which will be held at restaurant Lattanzi Ristorante, located at 361 W. 46th St. between 8th and 9th.

Wednesday, March 17, 2010

Meeting                                                             Time                                      Room

DCS/DSTF Meeting                                         9:00am-4:00pm                 Broadway 1&2 - 3^rd Floor

Lens Bevel Task Force                                  8:00am-12:00pm                Palace - 9^th Floor

Remote Order Entry Task Force                  1:00pm-5:00pm                   Broadway 3 - 3^rd Floor

LDS/Lens Marking Task Force                     1:00pm-5:00pm                  Palace - 9^th Floor

AR Steering Committee Dinner                   7:00pm-10:00pm                 Lattanzi Ristorante

Thursday, March 18, 2010

Meeting                                                            Time                                      Room

Lens Technical Committee                          8:00am-12:00pm              Ambassador 2 - 2^nd Floor

E&A/SRD Trends Presentation                   8:00am-10:00am               Gershwin Ballroom - 4^th Floor

OWA Board Meeting                                       9:00am-12:00pm              Minetta - 8^th Floor

Statistics Committee                                   11:00am-12:30pm              Gershwin Ballroom - 4^th Floor

SRD Steering Committee                            12:00pm-3:30pm               Ambassador 1 - 2^nd Floor

Country of Origin for Lenses                          1:00pm-5:00pm              Ambassador 2 - 2^nd Floor

Optical Industry Forum                                     1:00pm-5:00pm              Minetta - 8^th Floor

SRD Reception/Dinner                                        5:30pm-10pm              Lattanzi Ristorante

MLM Dinner                                                       6:00pm-10:00pm             Shula's

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 Elaine Kennedy, The Vision Council senior manager of membership, at (703)740-1099 or ekennedy@thevisioncouncil.org.