The Freestyle Libre Pro, which is a continuous glucose monitoring (CGM) system, was approved in September 2016 for use by healthcare professionals has not yet been approved for use by consumers, as described in this press release:
ABBOTT RECEIVES FDA APPROVAL FOR THE FREESTYLE LIBRE PRO™ SYSTEM, A REVOLUTIONARY DIABETES SENSING TECHNOLOGY FOR HEALTHCARE PROFESSIONALS TO USE WITH THEIR PATIENTS
Freestyle Libre Pro is a continuous glucose monitoring (CGM) system designed to provide a clear, visual snapshot of a patient's glucose levels, trends and patterns for up to 14 days
Requires no fingersticks to calibrate the system -- an advantage over other professional use CGM devices
Significantly lower cost than other professional CGM systems
Consumer version of the technology, FreeStyle Libre™, is currently under review by the U.S. Food and Drug Administration
What that means is that doctors can give the system to their patients so they can monitor the patients' blood glucose levels, but patients can't just buy it on their own to monitor their own blood glucose levels.
My question is, would it be illegal for a patient to obtain the Free Style Libre Pro on their own and to use it to monitor their own blood glucose levels? Is it only manufacturers, distributors, and doctors who are bound by the FDA regulations, or would consumers face criminal or civil penalties if they use it without FDA approval?