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Pre-Cert Program Will Start Off Slow With De Novo Framing, But Big Questions Remain

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.

ONE TME USE: Apple Watch ECG App
Digital health products like the new Apple Watch ECG app are already leveraging FDA's de novo pathway.

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 approach in which firms that make software-as-a-medical-device (SaMD) products undergo...

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