FDA has issued a proposed order to exempt certain Class II flow cytometry instruments from premarket notification (510(k)) requirements, subject to limitations and conditions. The agency will continue to review the relevant functionality of the devices when they are used clinically with an in vitro diagnostic reagent or a test kit that is subject to FDA premarket review.
The proposed exemption applies only to cytometry instruments used for counting or characterizing cells, applications that use well-understood and mature technology.
The intent of the proposed order is to reduce the regulatory burden on manufacturers by providing a more streamlined and efficient process to bring the instruments to market, and to make flow cytometry instruments used to count or characterize cells more accessible to healthcare providers.
In its order, FDA is establishing limitations and conditions on the proposed exemption, in order 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. FDA believes that these limitations, along with the general controls applicable to all medical devices, will ensure that such cytometry instruments will remain safe and effective.
Cytometry instruments used for sorting or collecting cells, and instruments that are used as automated hematology analyzers or that perform automated differential cell counts, will still require premarket notification (510(k)) clearance.
For further information, visit FDA.