FDA eases regulatory control of ingestible event markers as class II devices

The U.S. Food and Drug Administration is easing regulatory control of ingestible digital pills that can wirelessly transmit patient data, according to an announcement published in the Federal Register.

The final FDA order, which becomes effective on June 17, is classifying the devices into class II (special controls) in order to "provide a reasonable assurance of safety and effectiveness of the device," states the agency.

The FDA assigns devices to one of three regulatory classes based on the level of control necessary to assure their safety and effectiveness. As device class increases from class I, to class II to class III, the regulatory controls also increase, with class I devices subject to the least regulatory control, and class III devices subject to the most stringent regulatory control.

Ingestible event markers, devices used to record time-stamped, patient-logged events wirelessly, now have the class II designation. Last year, the FDA granted the Proteus ingestible event marker class II status, making Redwood City, Calif.-based Proteus Digital Health the first to receive such a classification and setting the standard for similar technologies moving forward.

"Going forward, any firm submitting a 510(k) premarket notification for an ingestible event marker will need to comply with the special controls named in the final administrative order," states the FDA's announcement.

The special controls are required by the FDA because general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of the devices. In its order, the FDA identified specific risks to health associated with this type of device and the measures required to mitigate these risks.

In July 2011, Proteus Biomedical (now called Proteus Digital Health) earned a patent for its ingestible patient monitor. The ingestible sensor (formally referred to as the ingestion event marker) is part of the Proteus digital health feedback system, an integrated, end-to-end personal health management system that is designed to help improve patients' health habits and connections to caregivers. In July 2012, the company announced that the FDA had cleared its ingestible sensor for marketing as a medical device.

"Directly digitizing pills, for the first time, in conjunction with our wireless infrastructure, may prove to be the new standard for influencing medication adherence and significantly aid chronic disease management," Dr. Eric Topol, professor of genomics at The Scripps Research Institute and author of The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare, said in the announcement.

To learn more:
- read the announcement