Bioelectronics Corp (BIEL)

[GetSeriousOK]

A Q submission is just a request for information.

Apparently, the FDA told them they need to submit a new 510(k).

A 510(k), whether it's submitted to the FDA or a 3PRO, requires evidence that the device is substantially equivalent to an existing device.

The existing device can be the ActiPatch or it can be the device they used for previous FDA clearances. Either way, BIEL will need clinical data to prove substantial equivalence.