The US Food and Drug Administration (FDA) issued a proposed order Tuesday to exempt certain flow cytometer instruments from 510(k) requirements.
The flow cytometer instruments are currently regulated by the agency as class II devices, which are subject to 510(k) reviews. But FDA’s Center for Devices and Radiological Health (CDRH) has determined premarket notification is no longer necessary to provide reasonable assurance of safety and effectiveness prior to market entry, partly due to factors identified in the proposed order.
The move seeks to reduce regulatory burden associated with 510(k) requirements, provide time and cost savings, as well as support greater accessibility. Flow cytometer instruments are used to count and characterize cells and are intended for use with cleared or approved in vitro
diagnostic (IVD) reagents.
The proposed order points to four main factors that the agency generally considers to make the determinations around class II device exemptions from premarket notification, citing a CDRH notice and subsequent guidance
from 1998. These relate to whether the device has a history of misleading claims or risks associated with inherent characteristics, whether integral characteristics for safe and effective device performance are well established, whether device changes will be easily detectable by users or not “materially increase” certain risks linked to use and the likelihood of device changes that result in a new classification.
CDRH reached the determination by assessing the need for 510(k) review against the four factors. The determination is also based on the agency’s experience and knowledge of the devices, which grew over the past 34 years, relevant reports or studies and its ability to limit a 510(k) review and an exemption.
The proposed 510(k) exemption is subject to limitations and conditions. Under the proposed order, the agency would continue reviewing relevant functionality when a flow cytometer instrument is intended to be clinically used with an IVD reagent or test kit that requires a premarket review. Performance must be demonstrated with fluorescent beads or detection materials that have been either FDA-cleared or 510(k) exempted and “coupled with fresh, fixed, or stabilized cells” to fall within the scope of a finalized exemption order. Design verification and validation would be subject to performance aspect mitigations as identified in 2001 guidance
on automated differential cell counters, among several other conditions.
“Cytometry instruments used for sorting or collecting cells and instruments that are used as an automated hematology analyzer or that perform automated differential cell counts will still require premarket notification (510(k)) clearance,” CDRH clarified in its announcement.