FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CDER Plans to Exempt Certain Flow Cytometers from 510(k) Requirements

March 7, 2019
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CDER plans to exempt a subcategory of flow cytometer devices regulated under product code OYE from premarket notification requirements.

The agency issued its proposal after deciding that it no longer needs premarket notification to show safety and effectiveness for certain flow cytometer devices, which are used to count or characterize human cells using lasers.

To meet exemption requirements, the device must not be indicated for sorting and collecting cells for IVD use or other clinical purposes and may not be an automated hematology analyzer.

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