FDA product code IFL: Polyethylene Glycol Preservative
IFL is the FDA product code for polyethylene glycol preservative. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. Devices under IFL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Polyethylene Glycol Preservative |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IFL devices
openFDA lists no recalls for product code IFL.
Frequently asked questions
What is FDA product code IFL?
IFL is the FDA product code for polyethylene glycol preservative. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IFL?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IFL
- Run a recall and safety report across every IFL manufacturer
- Watch product code IFL 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.