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Custom ophthalmic laser IDEs to get 10-day turnaround under FDA policy.

This article was originally published in The Gray Sheet

Executive Summary

CUSTOM OPHTHALMIC LASER IDE RESPONSE TIME OF 10 DAYS is being aimed for by FDA under its policy requiring physicians using home-built lasers for vision correction surgery to submit investigational device exemption applications by Jan. 15, 1997. FDA is compressing its normal 30-day deadline for acting on IDEs in anticipation of the increased resource demands that the custom-built eye laser applications will create in the FDA Office of Device Evaluation's Division of Ophthalmic Devices.

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