Certain Health Equipment Now Classified As “Low-Risk” By FDA

Medical devices originally believed to be high-risk are now considered low-risk

Various devices used for storing, transferring, and displaying medical data have been listed as “low-risk” by the Food and Drug Administration (FDA).

Listed before as devices with high risks, the health devices, both hardware and software, now do not have to undergo further review before entering the consumer market.

The devices in question are used for collection of data from diabetes measuring instruments, transferring of medical data between various equipment, and storing data used in the medical field.

Similar devices were previously suggested as having potential adverse affects for users, but officials believe these instruments carry very little risk at this point.

Additionally, experts were nervous about whether or not the devices were entirely reliable in data integrity, but that issue has since been resolved.

Officials explain obtaining, storing, and transferring the data will maintain reliability and the devices truly carry very little risk.