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U.S. Department of Health and Human Services

Product Classification

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Device medication management system, remote
Regulation Description Remote Medication Management System.
Definition A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; for a medical provider to remotely schedule the patient's prescribed medications; to provide notification to the patient when the prescribed medications are due to be taken; to release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command; and to provide to the medical provider a history of the event.The system is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic.
Physical State A remote medication management system consists of three primary components: control software (clinical and communications software), the medication delivery unit, and a specialized blister package containing the patient's prescribed medications that the patient receives from a pharmacy and stores in the medication delivery unit.
Technical Method A clinician using the clinical software enters the patient's prescribed medication schedule. The patient goes to a pharmacy and receives the prescription packaged in one or more blister pack discs. The medication delivery unit then dispenses the medication at the quantities and schedule that were prescribed by the clinician.
Target Area Intended for delivery of pill type medication.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeNZH
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.6315
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Remote Medication Management System
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible