FDA Qualifies WOUND-Q scales as Medical Device Development Tools

The USA Food and Drug Administration qualified 7 WOUND-Q scales as Medical Device Development Tools (MDDT). According to the FDA, “Medical device sponsors can use qualified tools and be sure they will be accepted by the FDA without the need to reconfirm the suitability and utility of the tool within the same context of use.”

The qualified scales measure the following domains:

  1. Wound Characteristics
    • Assessment
    • Drainage
    • Smell
  2. Health-Related Quality of Life
    • Life impact
    • Psychological
    • Sleep
    • Social