Extract to table

The March 2024 reclassification order directly affects the Lumina CGM System's submission pathway by confirming the Class II / 510(k) pathway for CGM systems of this type and by codifying the specific special controls that Solstice must address in its submission

entity responsible for the commercial distribution of the Lumina CGM System in the United States, must register as a U

Registration and listing must be completed prior to the commercial distribution of the device and must be updated annually

Solstice Ireland, as a foreign manufacturer, must also designate a U

30 and management review requirements — must be separately addressed to ensure full QSR compliance

As discussed above, a 510(k) premarket notification must be submitted to and cleared by FDA before the Lumina CGM System may be commercially distributed in the United States