FDA product code PFC: Cultured Human Cell Skin Dressing
PFC is the FDA product code for cultured human cell skin dressing. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under PFC reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers.
Classification
| Field | Value |
|---|---|
| Device name | Cultured Human Cell Skin Dressing |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PFC devices
openFDA lists no recalls for product code PFC.
Frequently asked questions
What is FDA product code PFC?
PFC is the FDA product code for cultured human cell skin dressing. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is PFC?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PFC
- Run a recall and safety report across every PFC manufacturer
- Watch product code PFC 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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