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Proposed infant apnea monitor standard based on bench testing is released by FDA.

This article was originally published in The Gray Sheet

Executive Summary

INFANT APNEA MONITOR STANDARD BASED ON BENCH TESTING rather than clinical trials is proposed by FDA in a Feb. 21 Federal Register notice. The revised version of the standard was expected to include clinical testing requirements, but FDA says that performance of apnea monitors currently on the market can be demonstrated without clinical trials. Comments on the proposal are due by May 22.
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