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FDA Proposed Rule Trims Preamendments Reclass List By Three

This article was originally published in The Gray Sheet

Executive Summary

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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Regulatory News In Brief

Primary mode of action: FDA lengthens the deadline for receiving stakeholder comments on the agency's proposed rule defining "mode of action" and "primary mode of action" to Aug. 20, following AdvaMed request for a 60-day extension, according to a June 24 Federal Register notice. FDA issued the proposed rule clarifying the mechanism for assigning jurisdiction of combination products May 7 (1"The Gray Sheet" May 10, 2004, p. 12). Comments initially were due July 6...

Regulatory News In Brief

Primary mode of action: FDA lengthens the deadline for receiving stakeholder comments on the agency's proposed rule defining "mode of action" and "primary mode of action" to Aug. 20, following AdvaMed request for a 60-day extension, according to a June 24 Federal Register notice. FDA issued the proposed rule clarifying the mechanism for assigning jurisdiction of combination products May 7 (1"The Gray Sheet" May 10, 2004, p. 12). Comments initially were due July 6...

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

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

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