Is it illegal for a consumer to obtain or use a non-FDA approved medical device?

Question

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?

Answer 1

The FDA approved the device as requiring a prescription (not OTC). FDA regulations govern the manufacture or distribution of devices and drugs, not the consumption. An overview of FDA regulation is here. They say they they are "responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States". The entire pile of regulations (21 CFR) is here. There has to be an underlying statute that authorizes the FDA to impose restrictions: that would be in Title 21 of the US Code. The specific law regulating medical devices is 21 USC 360. Congress can easily pass laws that restrict what businesses do (a consequence of the Commerce Clause of the Constitution), but they (theoretically) have a more limited ability to restrict what an individual does. Since there is no federal law prohibiting the use of a prescription device, it is not a crime to possess or use such a device.