Today the U.S. Food and Drug Administration (FDA) is issuing aproposed orderto exempt certain class II flow cytometry instruments frompremarket notification(510(k)) requirements, subject to limitations and conditions. The FDA will continue to review the relevant functionality of these devices when they are used clinically with an in vitro diagnostic device (IVD) reagent or test kit that is subject to FDA premarket review.

The proposed exemption applies only to cytometry instruments used forcounting or characterizing cells, which use well-understood and mature technology.

The intent of this proposed order is to:

Reduce the regulatory burden by providing a more streamlined and efficient process to bring these instruments to market

Make flow cytometry instruments used to count or characterize cells more accessible to health care providers.

Limitations and Conditions

In the proposed order, the FDA is establishing limitations and conditions on the exemption to provide a reasonable assurance of safety and effectiveness for certain flow cytometry instruments. To be considered exempt from premarket review, the performance of the instrument 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. The FDA believes these limitations along withgeneral controls for medical devices will ensure the cytometry instruments remain safe and effective.

Cytometry instruments used forsorting or collecting cellsand instruments that are used as anautomated hematology analyzer or that perform automated differential cell countswill stillrequire premarket notification (510(k)) clearance.

Submit Comments on the Proposed Order

Regarding this proposed orderthe US FDA is seeking comments and suggestions. The comment period will be open until May 5, 2019 in theFederal Registerunder docket number 2019-03967.

The proposed exemption applies only to cytometry instruments used for counting or characterizing cells, which use well-understood and mature technology.