QJY · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5725
Classification
FDA Product Code
QJY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5725
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.