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Device/IVD statistical guidances

This article was originally published in The Gray Sheet

Executive Summary

The Division of Biostatistics in FDA's Office of Surveillance and Biometrics is developing a guidance document on statistical considerations in the conduct of medical device clinical trials. The document, expected to be about 25 pages long, will provide recommendations on issues such as calculating sample size. The division hopes to have a rough draft of a separate statistical guidance for in vitro diagnostic clinicals completed by the end of January
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