Title 21 Part 880 → Subpart G → §880.6315

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6315

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6315

e-CFR data is current as of October 11, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6315

Title 21: Food and Drugs
Subpart G—General Hospital and Personal Use Miscellaneous Devices

§880.6315   Remote Medication Management System.

(a) Identification. A remote medication management system is a device composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended to store the patient's prescribed medications in a delivery unit, to permit a health care professional to remotely schedule the patient's prescribed medications, to notify 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 record a history of the event for the health care professional. The system is intended for use as an aid to health care professionals in managing therapeutic regimens for patients in the home or clinic.

(b) Classification. Class II (special controls). The special control is: The FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System.” See §880.1(e) for availability of this guidance document.

[72 FR 59177, Oct. 19, 2007]

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