21 CFR 880.6315 — Medication Management System, Remote
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6315
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NZH | Medication Management System, Remote | 2 | 2 | SaMD |
Special Controls
NZH — Medication Management System, Remote
*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.
eCFR
NZH — Medication Management System, Remote
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.
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