FDA product code QQQ: Guide And Positioner, Ophthalmic Drug Delivery Device
QQQ is the FDA product code for guide and positioner, ophthalmic drug delivery device. It is a Class I device, regulated under 21 CFR 886.4300 and reviewed by the Ophthalmic panel. Devices under QQQ reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
To provide a guide and/or positioner for filling of a drug delivery device.
Classification
| Field | Value |
|---|---|
| Device name | Guide And Positioner, Ophthalmic Drug Delivery Device |
| Device class | Class I |
| Regulation | 21 CFR 886.4300 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | Contact FDA |
Recalls for QQQ devices
openFDA lists no recalls for product code QQQ.
Frequently asked questions
What is FDA product code QQQ?
QQQ is the FDA product code for guide and positioner, ophthalmic drug delivery device. It is a Class I device, regulated under 21 CFR 886.4300 and reviewed by the Ophthalmic panel.
What device class is QQQ?
Class I, regulation 21 CFR 886.4300. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QQQ
- Run a recall and safety report across every QQQ manufacturer
- Watch product code QQQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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