Ophthalmic device trial guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA draft guidance entitled "Accountability Analysis for Clinical Studies for Ophthalmic Devices" published in the Aug. 4 Federal Register recommends that studies have 10% or less of patients lost to follow-up. Sponsors are advised to include a lost to follow-up analysis with a report on overall accountability. A suggested format to demonstrate overall accountability and "accountability by post-operative visit" also are included in the draft guidance. The deadline for comments is Nov. 2