FDA Clears ’Computerized Medication Box’ for U.S. Market

The U.S. Food and Drug Administration has cleared for marketing the INRange Systems’ Electronic Medication Management Assistant (EMMA), a programmable device that stores and dispenses prescription medication for patients’ use in the home.

Essentially a computerized medication box, EMMA was designed to be used under the supervision of a licensed health care provider. EMMA can reduce drug identification and dosing errors, and allow health care professionals to monitor patient adherence to medication regimens in an outpatient setting. It may be especially useful for aging patients, as well as those with complex medication regimens such as patients with HIV.

“FDA’s clearance of the INRange remote medication management system puts an important safety tool directly in the hands of patients and their health care providers,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “It will help take away some of the confusion patients can experience when taking prescription medications, and allow care providers to more closely monitor their patients’ medications between office visits.”

A 2006 Institute of Medicine report estimated that medication errors harm at least 1.5 million people in the United States annually.

EMMA consists of a medication delivery unit and two-way communication software that allows a health care professional to remotely manage prescriptions stored and released by the patient-operated delivery unit. The delivery unit is about the size of a bread box and plugs into a standard power outlet.

EMMA stores prescription medications, emits an audible alert to the patient when the prescribed medications are scheduled to be taken, and releases them onto a delivery tray when activated by the patient at the appropriate time. It uses a Web-based application for a health care professional, such as a doctor or pharmacist, to remotely schedule or adjust a patient’s prescribed medications, and provides the health care professional with a history of each time patients access their medications.

FDA reviewed safety and effectiveness information for EMMA under the “de novo” classification process. The ability to petition for “de novo” initial classification was added under the Food and Drug Administration Modernization Act of 1997 to establish an additional way for novel, but less risky, devices to get to market.

The EMMA system is manufactured by INRange Systems based in Altoona, Pa.