FDA Eases Rules on Ingestible Medication Trackers

5-18-2013 8-23-06 PM

The FDA has published an order setting the classification for up-and-coming “smart pill”  technology that will help to relax government oversight on the devices. Smart pills are comprised of small sensors that are swallowed and then transmit messages to the user from within the body.

The first smart pill to be approved by the FDA was submitted by Proteus Digital Health, maker of miniature medication tracking sensors that are ingested with a placebo or other drug and, once inside the stomach, collect information on the timing of digestion and transmit the information to a patch worn on the skin. The patch, in turn, transmits information to a smartphone app where medication compliance is monitored over time.

The FDA has ruled the technology, formally known as an “ingestible event marker” as a class two medical device, which is less restrictive than a class three device – the status that new-to-market technologies are typically assigned.

The FDA had granted ingestible event markers class two status in 2012, but the ruling was temporary. That changed on Thursday as they published an order that makes the classification permanent.

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