| Device |
infusion pump, drug specific, pharmacy-filled |
| Regulation Description |
Infusion pump. |
| 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. |
| Physical State |
A Pharmacy-Filled, Drug Specific Infusion System includes the delivery device, reservoir or syringe, and any administration sets and / or catheters or needles to infuse the specific drug and may contain materials needed to assist the pharmacist in filling and shipping the device containing an approved drug. This excludes compounded drugs. |
| Technical Method |
A Pharmacy-Filled, Drug Specific Infusion System infuses a specific drug into the body in accordance with FDA approved labeling. The infusion system may be filled at a location other than point of care under conditions as outlined in the drug label. |
| Target Area |
In accordance with FDA approved labeling, a Pharmacy-Filled, Drug Specific Infusion System is intended for the route of administration specific to the approved drug label |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | QJY |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5725
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
