FDA Proposes to Exempt Some Flow Cytometers

FDA says it is soliciting comments on a proposal to exempt some flow cytometer instruments from 510(k) premarket notification requirements. A 3/6 Federal Register notice says the agency has determined, based on established factors, that the devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. All other Class 2 devices classified under FDA’s automated differential cell counter regulation would continue to be subject to premarket notification requirements.

The notice says the agency proposal is based, in part, of its knowledge of the device, including experience reviewing the devices over the past 34 years, the ability to review the relevant functionality of the devices when they are used clinically with an IVD reagent that is subject to review, and relevant reports or studies on device performance and FDA’s ability to limit an exemption. The notice includes proposed conditions and limitations of the exemption.