The FDA is announcing qualification of the WOUND-Q instrument through the Medical Device Development Tools (MDDT) program. WOUND-Q is a new patient-reported outcome instrument, to measure outcomes in individuals with nonhealing chronic wounds in any area of the body.
The qualified WOUND-Q instrument:
- Can measure outcomes important to individuals with nonhealing chronic wounds (lasting three months or longer) for medical device development.
- Is a set of seven separate scales to assess aspects of wound characteristics and impact on health-related quality of life.
| Qualified Medical Device Development Tools |
