Surgeons To FDA: Surgical Medical Devices Need More Real-World Data

Surgeons and medical professors urged FDA to modify its approach to robotically-assisted surgical devices (RASD) so that assessment of such devices includes more real-world experience, with one physician saying that money provided in the 21st Century Cures Act should be used for developing a database for every operation as well as for tapping into other databases to assist professional societies. The issue came up at a public workshop FDA held last Monday (July 27) to obtain feedback on scientific, clinical...