Ophthalmic Devices Panel Meeting
FDA Executive Summary
Phakic IOL Postmarket Experience:
The regulatory background and history of phakic intraocular lenses (PIOL) will be presented by the FDA during the Panel Meeting. Attention will be brought to FDA’s PIOL website - http://www.fda.gov/cdrh/phakic/index.html. For a print-out of the website’s contents, please see Attachment 1. Panel members will be asked to recommend modifications / additions to the FDA’s PIOL website.
Many national and international consensus standards address aspects of safety and/or effectiveness relevant to medical devices. FDA staff has been an active participant in the development of many of these standards and has an official program devoted to recognition of national and international consensus standards. Availability of FDA recognized standards allow sponsors to have insight into test methods and requirements that FDA has found acceptable, thereby streamlining the premarket review process. There are currently two PIOL standards; the American National Standards Institute (ANSI) and the International Standards Organization (ISO). Please see Attachment 2 for excerpts from these standards. The standards recommendations regarding clinical trials of PIOLs for assessment and clinical characterization of new devices will be outlined during the meeting. Suggestions for future revisions will be welcomed by the FDA during the Panel’s discussion. FDA will then bring these revision recommendations to ISO and ANSI.
FDA will discuss currently available avenues of device adverse event reporting to the FDA, including Medical Device Reporting (MDR) and Medwatch. FDA will introduce SightNet and explain how the safety of PIOL devices will be monitored in the postmarket period through this cooperative network of hospitals and outpatient centers. Please see Attachment 5 for introductory information and a print-out from CDRH’s website about the MedSun Product Safety Network of which SightNet is a part. You can visit the web page directly at http://www.fda.gov/cdrh/Medsun/. Panel members will be asked for their recommendation on specific PIOL information to be collected by SightNet.
LASIK Postmarket Experience:
The FDA will present the regulatory background and history of refractive lasers during the Panel Meeting. Currently available LASIK patient education materials will be discussed. Specifically, an outline of typical patient labeling (Attachment 6) and FDA’s LASIK website - http://www.fda.gov/cdrh/lasik/. For a print-out of the website’s contents, please see Attachment 7. Panel members will be asked to recommend modifications / additions to the FDA’s patient labeling and LASIK Website.
FDA is currently evaluating the ANSI Refractive Laser standard for recognition. The standard can be recognized in its entirety, in part, or with specific additions. The standard’s recommendations regarding clinical trials for the assessment and clinical characterization of refractive lasers will be outlined and discussed during the meeting. Any recommendations made by the Panel members will be considered in our recognition evaluation of this standard. The current ANSI refractive laser standard will also be discussed. Please see the enclosed excerpts from the standard (Attachment 8).
FDA convened a Postmarket Issue (PMI) action team to assess aspects of the postmarket Quality of Life (QOL) experience with LASIK devices. How the LASIK PMI Action Team went about the assessment and the conclusions arrived at as a result will be explained. Attachment 9 contains a summary of the LASIK PMI Action Team’s work and their conclusions.
In an effort to explore a cost-effective, efficient way to gather clinical data on Patient Reported Outcomes (PROs) for future ophthalmic clinical trials, FDA and the National Eye Institute (NEI) are currently conducting a joint collaborative study. This will be the first study to compare the computerized, web based and paper-based versions of the previously validated questionnaires used to assess Quality of Life (QOL) in subjects with ocular disease. This study’s protocol will be presented to the Panel (Attachment 10).
In an effort to discuss the feasibility of a large,
postmarket, multi-centered trial to evaluate quality of life after LASIK, FDA joined
forces with the NEI, the American Society of Cataract and Refractive Surgeons
(ASCRS), and the
FDA will discuss how the postmarket safety of LASIK devices will be monitored through the SightNet cooperative network of hospitals and outpatient centers. Panel members will be asked for their recommendation on specific LASIK information that should be collected by SightNet network sites.
Please note there are no Attachments 3 and 4.