Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA's current authorities.
US FDA is taking a cautious approach to rolling out a new testing phase of its pre-certification program for digital health products within legal limits, according to experts. But that also means the new paradigm could be limited in scope in the near term.
FDA has been working for more than a year in a pilot collaboration with nine companies to develop the pre-cert...
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