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
You may also be interested in...
Regulatory News In Brief
FDA issues procedures governing reviewers' requests for additional pre-market data from sponsors. Agency extends comment period for its de novo and 510(k) modification draft guidances. More regulatory briefs.
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