Eyeworld

EW MEETING REPORTER 64 May 2011 on the FDA's three-part LASIK Qual- ity of Life Study, launched in 2009 through collaborative efforts among the FDA, National Eye Institute, and Department of Defense. In the first stage of the project, a web-based questionnaire was devel- oped to evaluate patient-reported outcomes after LASIK. Dr. Hofmeister reported on the second stage, which is a single-arm, prospective clinical study called Pa- tient-Reported Outcomes with LASIK (PROWL-1). In PROWL-1, 550 active duty military personnel electing LASIK for myopia, hyperopia, and astigmatism will report on their satisfaction lev- els at 1, 3, and 6 months post-op. Malvina Eydelman, M.D., director, Division of Ophthalmic, Neurologi- cal and Ear, Nose and Throat Devices in the Office of Device Evaluation, announced the next phase of the LQOL Study. On March 28, the FDA began the recruitment of sites for the next phase of the LASIK study. The RFP, posted to the FDA website on March 29, announced that the next phase is identifying five refrac- tive surgery clinical sites throughout the United States to participate in a post-marketing clinical study to evaluate a questionnaire for measur- ing the level of patient satisfaction and visual symptoms at 1 and 3 months following LASIK surgery. Dr. Eydelman also gave an overview of ophthalmic medical de- vices and ways in which innovation can be taken through the regulatory process. One way is to maximize the quality of the pre-market submis- sions and use FDA resources early in the process. Those resources include product determination, device classi- fication, guidance, and standards, Dr. Eydelman said. "Maximizing the quality of the premarket submissions plus the many ongoing CDRH efforts to fos- ter innovation and promote science- based, consistent device evaluations will lead to expedited medical device innovation," Dr. Eydelman said. Of particular interest were possi- ble changes to the 510(k) approval process. There are currently two types of medical device approval processes, thanks to an amendment to the Food, Drug and Cosmetics Act. The first grants approval after stringent pre-market testing; the other—510(k)—is an expedited process enacted so that manufactur- ers can continue innovating without heavy regulatory burdens. The 510(k) has become the most com- mon path toward clearance for new devices. "Changes to the 510(k) process will have a huge impact on the prac- tice of medicine," said Michael W. Belin, M.D., chairman of the ASCRS FDA committee. The FDA is currently consider- ing changes and implementing 25 "actions" in 2011. The CDRH is waiting until the summer and an independent Insti- tute of Medicine (IOM) evaluation before deciding whether to imple- ment another set of recommenda- tions that include: • Consolidating the terms "indica- tion for use" and "intended use" into a single term, "intended use;" • Expanding statutory authority to consider off-label use when deter- mining the intended use of a de- vice; • Issuing guidance on when a device should no longer be available for use as a predicate; • Issuing a regulation on its rescis- sion authority; • Requiring manufacturers to keep one unit of a device available; • Issuing guidance to create a "Class IIb"; and • Seeking greater authorities to re- quire post-market surveillance studies as a condition of clearance for certain devices. Two of those items are of spe- cific concern to ASCRS and other specialty societies, Dr. Belin said. He said ASCRS is concerned with the possible expansion of the group's au- thority to consider off-label use and require post-market surveillance. "In general, medical device companies and organized medicine have concerns on the effect that some of the changes will have on the ability to bring new products to market," Dr. Belin said. "We have al- ready approached the point where the time and expense to bring a product to market has hindered many companies from marketing in the U.S., let alone producing in the U.S." On the other hand, some prod- ucts available outside the U.S. have been removed from the market be- cause of safety reasons. "It is a constant battle between speed, efficacy, market demand, and safety," Dr. Belin said. ASCRS, through its association with the Alliance of Specialty Medi- cine, suggested that the process ex- pand the comment period to 90 days. Reporting live from the 2011 ASCRS•ASOA Symposium and Congress, San Diego, Calif. Editors' note: This Meeting Reporter contains original reporting by the EyeWorld news team.

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