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FDA Seeks to Exempt Some Flow Cytometers From 510(k) Clearance

NEW YORK (360Dx) – The US Food and Drug Administration today 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In an unpublished proposed rule document filed with the Federal Register, FDA said that under the 21st Century Cares Act, which became law in December 2016, FDA can exempt some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.

Medical devices are classified by FDA into three classes with Class I posing the lowest risk to patients and Class III devices posing the highest risk. To determine whether a Class II device may require 510(k) review, the FDA considers whether the device has a significant history of false or misleading claims or of risks associated with inherent characteristics of the device. It also considers whether the characteristics that are necessary for the device to be used safely and effectively are well established. Further, FDA will determine if changes to a device that could affect its safety and effectiveness will be "readily detectable by users by visual examination or other means … before causing harm," or if those changes won't materially increase the risk of injury, a wrong diagnosis, or ineffective treatment.

Lastly, FDA considers whether any changes to a device would likely result in the device's reclassification[B1] .

In FDA's proposed order, for a flow cytometer to be exempted from 510(k) review, its performance must be demonstrated with either fluorescent beads or detection materials "coupled with fresh, fixed, or stabilized cells that have been cleared, approved, or exempted from the premarket notification requirement," FDA said in its statement.

It added that it seeks to exempt some flow cytometers from required 510(k) clearance in order to reduce the regulatory burden "by providing a more streamlined and efficient process to bring these instruments to market," and to make those instruments that count or characterize cells more accessible to healthcare providers.

The agency is accepting comments on its proposed order until May 5.