FDA product code OWD: Somatic Gene Mutation Detection System
OWD is the FDA product code for somatic gene mutation detection system. It is a Class III device, reviewed by the Pathology panel. Devices under OWD reach the market by PMA; FDA lists no cleared 510(k)s for it. 19 PMA applications cite this product code. FDA has posted 13 recalls for OWD devices, 6 initiated in the last five years.
Definition
The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.
Classification
| Field | Value |
|---|---|
| Device name | Somatic Gene Mutation Detection System |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OWD devices
13 product recalls in 10 recall events; 6 initiated in the last five years and 7 still open. Most recent: 2023-08-22.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 5 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code OWD?
OWD is the FDA product code for somatic gene mutation detection system. It is a Class III device, reviewed by the Pathology panel.
What device class is OWD?
Class III. Typical premarket route: PMA.
Have OWD devices been recalled?
Yes: 13 product recalls across 10 recall events; the most recent began 2023-08-22.
Next steps
- Run an FDA pathway report with predicate devices for product code OWD
- Run a recall and safety report across every OWD manufacturer
- Watch product code OWD 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times