Navigant’s Joe Galatowitsch via the Minneapolis StarTribune
It’s not only common, but a “best practice” for device companies to continue developing new clinical data about specific uses of devices after the initial FDA approval or clearance, Navigant’s Joe Galatowitsch told the StarTribune. In general terms, the clinical community may sometimes quickly adopt unapproved uses of a new device, and then have to pull back a bit as the manufacturer works to provide the best clinical evidence it can, said Galatowitsch. In those situations, there may be a stronger desire to develop new evidence when the product use is concentrated in unapproved procedures.
When the clinical community and industry and the regulatory bodies together see that a given medical technology is being used far removed from its initial indication, there is a sort of a shared responsibility of all three parties to say, ‘How do we think about learning more about the use of this technology in these far-flung use cases that were never really studied in a great amount of detail?’”