Dive Brief:

• FDA is planning to exempt some flow cytometry instruments from 510(k) requirements using powers granted by the 21st Century Cures Act.

• Acting on its own initiative, FDA has determined it's unnecessary to subject cytometry instruments used for counting or characterizing cells to premarket notification requirements, as the agency says it is very familiar with the devices and confident risks can be managed outside the 510(k) pathway.

• FDA thinks the changes will reduce the regulatory burden on the sector, making it easier to get products to market and thereby facilitating adoption by healthcare providers.

Dive Insight:

Flow cytometers count or characterize human cells by passing them through one or more lasers and collecting the signals they generate. Having regulated flow cytometers for 34 years, FDA thinks it has a solid enough handle on the risks posed by the devices to relax regulations on the category.

Under FDA’s proposal, flow cytometers that use well-understood and mature technology to count and characterize cells will be exempt from 510(k) requirements.

To be considered exempt, a company will need to demonstrate the performance of its device with fluorescent beads or detection reagents that have been cleared, approved or exempted from 510(k) requirements by FDA. The agency wants companies to consult FDA-recognized consensus standards to understand how to generate and analyze the required performance data.

By documenting the performance of particular aspects of the instruments, FDA thinks manufacturers can mitigate the risks identified in the special controls for cell counters through design verification and validation efforts, rather than through 510(k) requirements, and thereby ensure the devices remain safe and effective.

The exemption will not apply to the use of flow cytometers in clinical settings in conjunction with in vitro diagnostic reagents or test kits, nor to instruments used for sorting or collecting cells. Devices that perform automated differential cell counts or are used as an automated hematology analyzer must still follow the 510(k) pathway, too.

FDA is accepting feedback on the proposal for 60 days. Under terms of the powers granted to it by the Cures Act, FDA must make its final determination on the exemption within the next 120 days.