FDA product code OTW: Research Use Only/Clinical Toxicology
OTW is the FDA product code for research use only/clinical toxicology. It is a Not classified device, reviewed by the Clinical Toxicology panel. Devices under OTW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
For research use only and for products imported into the US only.
Classification
| Field | Value |
|---|---|
| Device name | Research 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 OTW devices
openFDA lists no recalls for product code OTW.
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 OTW?
OTW is the FDA product code for research use only/clinical toxicology. It is a Not classified device, reviewed by the Clinical Toxicology panel.
What device class is OTW?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OTW
- Run a recall and safety report across every OTW manufacturer
- Watch product code OTW 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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