NZH · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6315
Classification
FDA Product Code
NZH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6315
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.