Public Workshop: FDA/AAO Workshop on Developing Novel Endpoints for Premium Intraocular Lenses, March 28, 2014

By Effective Medicine  On  In Medical Devices Tagged  

The Food and Drug Administration (FDA) is announcing the following co-sponsored public workshop entitled “FDA/American Academy of Ophthalmology (AAO) Workshop on Developing Novel Endpoints for Premium Intraocular Lenses.”   

The purpose of this workshop is to discuss current challenges in the assessment of innovative intraocular lens (IOL) designs with a focus on endpoint methodologies used in evaluating IOL safety and effectiveness.  The primary goal of the workshop is to improve the regulatory science around the approval of premium IOLs and the efficiency with which they get to market. 

Link for FDA Campus Information

Webcast

Webcast participants will be sent technical system requirements and will be sent connection access information after registration. If you have never attended a Connect Pro event, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit: http://www.adobe.com/go/connectpro_overview.

Preliminary Agenda

Registration to Attend the Workshop

Registration is $250 for Academy members, $400 for non-members and available on a first-come, first-served basis.  Persons interested in attending this public workshop must register online.  The deadline for registration is March 27, 2014 at 5:00 p.m. EDT.  There will be no on-site registration on the day of the public workshop.  Early registration is recommended because facilities are limited and, therefore FDA may limit the number of participants from each organization.  To register for the public workshop, please visit the American Academy of Ophthalmology (AAO) website:  www.aao.org/IOLworkshop

Those interested in attending but are unable or unwilling to access the electronic registration site should fax the PDF form on the AAO website to (415) 561-8575. Those without internet access should contact AAO Customer Service to register at (415) 561-8540 or (866) 561-8558 (toll free).  Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number.  If there are any questions with registration, please contact the AAO administrative offices at (415) 561-8540.  Registrants will receive confirmation after they have been accepted.  You will be notified if you are on a waiting list.   

[email protected].

For questions regarding workshop content please contact Dr. Michelle Tarver, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2504, Silver Spring, MD 20993-0002, 301-796-5620, email: [email protected].




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