Eye Laser Industry Sees Minimal Impact From FDA LASIK Panel Meeting
This article was originally published in The Gray Sheet
Executive Summary
Laser vision correction device makers likely will not see major, direct fallout from a recent FDA panel meeting examining patient quality-of-life issues following laser-assisted in situ keratomileusis (LASIK), according to industry
You may also be interested in...
FDA Escalates Engagement With LASIK Providers In Letters To Medical Societies
In addition to building pressure on the LASIK device field, recent letters to eye surgery and ophthalmology societies raise questions about FDA’s authority over physician activities.
FDA Instructs LASIK Facilities On Reporting Regs Following Warning Letters
CDRH is stepping up communications with LASIK user facilities and professional societies to help clarify the agency's requirements for medical device reporting in the wake of 17 warning letters issued in October, according to Tim Ulatowski, director of the Office of Compliance at the center
FDA Instructs LASIK Facilities On Reporting Regs Following Warning Letters
CDRH is stepping up communications with LASIK user facilities and professional societies to help clarify the agency's requirements for medical device reporting in the wake of 17 warning letters issued in October, according to Tim Ulatowski, director of the Office of Compliance at the center