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CDRH-Wide Preamendments Reclassifications Could Finish In 2-3 Years

This article was originally published in The Gray Sheet

Executive Summary

CDRH's Division of Clinical Laboratory Devices anticipates wrapping up preamendments reclassifications in six to 12 months

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FDA Proposed Rule Trims Preamendments Reclass List By Three

PMAs would be required for indwelling blood oxyhemoglobin concentration analyzers, cardiopulmonary bypass pulsatile flow generators and ocular plethysmographs, according to a 1Nov. 18 FDA proposed rule

FDA Proposed Rule Trims Preamendments Reclass List By Three

PMAs would be required for indwelling blood oxyhemoglobin concentration analyzers, cardiopulmonary bypass pulsatile flow generators and ocular plethysmographs, according to a 1Nov. 18 FDA proposed rule

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