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ISO/ANSI Standard On Viscosurgical Devices Calls For Study Of 138 Patients

This article was originally published in The Gray Sheet

Executive Summary

Approval of premarket approval applications for ophthalmic viscosurgical devices would require clinical evaluation of a minimum of 138 patients in both study and control arms over three months under a draft standard developed by an International Standards Organization/American National Standards Institute project group with input from FDA.
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