FDA product code PDB: Investigational Use Only - Clinical Toxicology
PDB is the FDA product code for investigational use only - clinical toxicology. It is a Not classified device, reviewed by the Clinical Toxicology panel. Devices under PDB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Investigational use only and for products imported into the US only.
Classification
| Field | Value |
|---|---|
| Device name | Investigational Use Only - Clinical Toxicology |
| Device class | Not classified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for PDB devices
openFDA lists no recalls for product code PDB.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- Q4240 — Corecyte, for topical use only, per 0.5 cc
- Q4241 — Polycyte, for topical use only, per 0.5 cc
Frequently asked questions
What is FDA product code PDB?
PDB is the FDA product code for investigational use only - clinical toxicology. It is a Not classified device, reviewed by the Clinical Toxicology panel.
What device class is PDB?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PDB
- Run a recall and safety report across every PDB manufacturer
- Watch product code PDB 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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