The Food and Drug Administration’s draft guidance on the laser-assisted in situ keratomileusis, or LASIK, surgical procedures used to correct common vision problems has proven highly divisive.
Medtech trade group AdvaMed took the “unusual step” of asking the FDA to withdraw the draft because of “numerous concerns” with the text, Healthcare Dive reports. The American Society of Cataract and Refractive Surgery also called for the withdrawal of guidance it branded “biased and misleading.”
Other organizations including the Society for Excellence in Eyecare and the Office of the Attorney General of Kentucky spoke out against the draft. Still, a few comments were more positive. The American Optometric Association, or AOA, called the proposal “timely and beneficial.” Read more.
