US FDA has proposed a new rule to exempt Cytometry instruments used for counting or characterizing cells (a well-understood and mature technology), from premarket notification requirements. 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 (i.e., 510(k)) clearance.
Proposed rule in federal register: https://www.govinfo.gov/content/pkg/FR-2019-03-06/pdf/2019-03967.pdf
