This PDF is the current document as it appeared on Public Inspection on 12/18/2013 at 08:45 am.
Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the following public workshop entitled “FDA/American Academy of Ophthalmology (AAO) Workshop on Developing Novel Endpoints for Premium Intraocular Lenses.” The main topic of this workshop is the current challenges in the assessment of innovative intraocular lens (IOL) designs with a focus on endpoint methodologies used in evaluating IOL safety and effectiveness. Experts in subjects ranging from patient reported outcomes to objective measures of accommodation will give talks on the latest developments in the field. Participants will then engage in in-depth discussions of the pros and cons of various methods used to assess premium IOLs, and work to devise a plan to further promote innovation in this device area. The primary goal of the workshop is to improve the regulatory science for evaluating premium IOLs, which in turn may enhance the efficiency with which safe and effective premium IOLs get to the market. This public workshop is being rescheduled due to the government shutdown.
Date and Time: The public workshop will be held on March 28, 2014, from 8:30 a.m. to 5:30 p.m. Materials may be picked up starting at 7:30 a.m.
Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact: Michelle Tarver, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-5620, FAX: 301-847-8126, email: firstname.lastname@example.org.
Registration: AAO will charge a registration fee to cover its share of the expenses associated with the workshop. The registration fee is $250 for Academy members and $400 for non-members. Registration is available on a first-come, first-served basis. Persons interested in attending this public workshop must register online. The deadline for online registration is March 27, 2014, at 5 p.m. EDT. There will be no onsite 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 AAO Web site (http://www.aao.org/meetings/iol_workshop.cfm). Those interested in attending but unable to access the electronic registration site should fax the PDF form on the AAO Web site (http://www.aao.org/meetings/upload/FDA_iol_workshop_reg.pdf) 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.
This public workshop is being rescheduled due to the government shutdown. It was originally scheduled for October 11, 2013. Those who registered for the original workshop date were contacted by AAO individually and offered either a complete refund or the option to have those monies applied to the rescheduled date registration. Any questions about this process should be addressed to AAO Customer Service at 415-561-8540 or 866-561-8558 (toll free).
Food and beverages will be available for purchase by participants during the workshop breaks.
If you need special accommodations due to a disability, please contact Ms. Susan Monahan at email@example.com or 301-796-5661 no later than March 14, 2014.
For more information on the workshop, please see FDA's Medical Devices News & Events—Workshops & Conferences calendar at http://Start Printed Page 76843www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
Streaming Webcast of the Public Workshop: The morning session but not the afternoon session of this public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. EDT, March 14, 2014. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after March 24, 2014. If you have never attended a Connect Pro event before, 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. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)
Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcript will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)End Preamble Start Supplemental Information
Cataract surgery is the most commonly performed elective procedure in the United States with over 3 million patients being implanted with an IOL. Over the past two decades, IOLs have undergone significant design changes allowing them to correct for a spectrum of visual distances and refractive errors. As IOL technology evolves, some endpoints for the evaluation of the technology are also evolving. Endpoints and strategies for assessing the relative safety and effectiveness of these innovative lens designs are in various stages of development. At this workshop, not only will some of these novel endpoints and the challenges with assessments of these endpoints be identified, but these endpoints also will be prioritized for further discussion, development, and validation. Breakout sessions following the didactic portion of the workshop will allow for more in-depth group discussions of potential approaches to address these challenges.
The workshop seeks to involve industry and academia in addressing the challenges in the development of novel endpoints for premium IOLs. By bringing together all of the relevant stakeholders, which include clinicians, researchers, industry representatives, and regulators, to this workshop, we hope to facilitate the improvement of regulatory science in this rapidly evolving product area.
FDA and AAO recognize the unique opportunity this workshop provides for all stakeholders of the ophthalmic device community and that the knowledge and education provided from this workshop will further strengthen our mission of protecting the public health.
II. Topics for Discussion at the Public Workshop
Topics to be discussed at the public workshop include, but are not limited to:
- Safety assessments for premium IOLs and how they could differ from those for monofocal IOLs.
- Patient-Reported Outcome (PRO) measures and the need to develop and validate them for assessing the safety and effectiveness of premium IOLs.
- Objective assessments of accommodation and their challenges.
- Subjective assessments of accommodation and Extended Depth of Focus (EDF) and their challenges.
These topics will be presented by experts in the associated area and the afternoon will allow for more in-depth discussions of the given topics in small breakout sessions.Start Signature
Dated: December 12, 2013.
Assistant Commissioner for Policy.
[FR Doc. 2013-30148 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P