PWB Health Limited - Comment

Summary – PWB Health Ltd have been marketing their Breastlight product for over 2 years in the EU, Canada and other countries and have a growing body of evidence to support its safety and effectiveness. We have new valid and scientific clinical trials data and user trial data which support the products intended use as an aid to breast self examination. We would like to encourage the FDA to consider a request that a home use, non diagnostic breast transilluminator whose intended purpose is as an aid to breast self examination be re-classified as a class 1 medical device. We have addressed the FDA’s electrical shock and optical radiation concerns in the product design, manufacture and testing of the product. We have also addressed the potential for missed or delayed diagnosis thought the information provided with the device. This has been thoroughly tested in user studies. We would encourage the FDA to also consider the positive benefits of using the device including increased frequency of checking, increased confidence in checking, increased number of women carrying out checks, increase in confidence that person is carrying out an effective examination, detection of non palpable cancers between regular scheduled mammogram, positive experience by women with inherently lumpy breasts.