FDA seeks to exempt some flow cytometers from 510(k) clearance

 The US Food and Drug Administration announced a proposal to exempt certain Class II flow cytometry instruments from the 510(k) process for marketing in the US.

In a statement, the agency said that the proposed exemption would apply only to cytometry instruments that are used for counting or characterizing cells, which it said is a “well-understood and mature technology.”

The FDA emphasized that cytometry instruments used for sorting or collecting cells and instruments used as an automated hematology analyzer or that perform automated differential cell counts would not be exempt under the proposed order and would still require 510(k) clearance.

In an unpublished proposed rule document filed with the Federal Register, FDA said that under the 21st Century Cares Act, which became law in December 2016, FDA can exempt some Class II devices from 510(k) clearance requirements if the agency believes the process is not necessary to ensure the safety and effectiveness of the device.