March 28, 2014
The Food and Drug Administration (FDA) and the American Academy of Ophthalmology are jointly sponsoring a public workshop to identify challenges to intraocular lens (IOL) innovation and develop an action plan for delivering premium IOL technologies more quickly to market.
This sets a precedent for FDA collaboration with a medical specialty society to enhance innovation in the United States in an evolving area of medical devices. Results expected from this workshop include the development of consensus clinical statements and white papers, as well as proposals for preclinical and clinical research studies to enhance the efficiency of bringing safe and effective premium IOLs to the market.
Malvina B. Eydelman, MD, Director of the Division of Ophthalmic, Neurologic and Ear, Nose and Throat Devices, at the FDA said, "This innovative approach to ophthalmic endpoint development is a game changer. Not only will it allow experts to address the challenges facing endpoint development for premium IOLs, but it will also incorporate input from all interested parties to produce prioritized approaches to measure them." (January 2014, Eyenet)
The workshop will feature expert talks on the latest developments in the field and interactive discussions of the pros and cons of various methods used to assess premium IOLs.
Read the detailed agenda (PDF 30 KB)
Read Breakout Session discussion questions (PDF 80 KB)
FDA website and Federal Register
The workshop is being developed by the following planning committee:
American Academy of Ophthalmology
- Malik Kahook, MD, co-chair
- Thomas Oetting, MD, co-chair
- John Berdahl, MD
- David Chang, MD
- Nicole Fram, MD
- Thomas Harvey, MD
- Douglas Koch, MD
- Samuel Masket, MD
- Walter Stark, MD
- Elizabeth Yeu, MD
- Malvina Eydelman, MD
- Don Calogero, MS
- Gene Hilmantel, OD, MS
- Tina Kiang, MD
- Eva Rorer, MD
- Michelle Tarver, MD, PhD
This meeting will be held beginning at 8:30 a.m. on Friday, March 28, 2014, at the FDA White Oak Campus in Silver Spring, Md. Get more information about the location, including parking and other details, on the logistics page.
Attendance costs are:
- Live attendance with meals (breakfast and lunch): $300 for Academy members, $450 for non members
- Live attendance without meals: $250 for Academy members, $400 for non members
- Virtual attendance via webinar: $250 for Academy members, $400 for non members (details on the webcast will be available closer to the meeting)
The registration fee includes printed materials.
Registration is now closed.
Questions regarding the workshop can be directed to:
Flora Lum, MD
H. Dunbar Hoskins, Jr., MD Center for Quality Eye Care
American Academy of Ophthalmology
The American Academy of Ophthalmology is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
For the live course:
The American Academy of Ophthalmology designates this live activity for a maximum of 7.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
For the webinar:
The American Academy of Ophthalmology designates this live activity for a maximum of 4.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.