ARTICLE SUMMARY:
Real-world, observational data sources are attracting massive interest in the medical device space as tools to support regulatory decisions and more. But there certainly is not full consensus about what they are good for, as was laid bare at a recent FDA advisory panel meeting investigating safety data for peripheral artery disease devices.
Are real-world data from registries, insurance claims and the like the device sector’s savior from imperfect and expensive randomized controlled trial practices, or are they full of empty promises?
