Ophthalmic device trial guidance
This article was originally published in The Gray Sheet
FDA draft guidance entitled "Accountability Analysis for Clinical Studies for Ophthalmic Devices" published in the Aug. 4 Federal Register recommends that studies have 10% or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format to demonstrate overall accountability and "accountability by post-operative visit" also are included in the draft guidance.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
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