Hello,
I haven't read many posts on this topic yet, so excuse me if this was addressed previously...
Per the 21st Century Cures Act, decision support software is not to be FDA regulated unless it poses a significant risk to patient. Is there a polite and effective way to address this with FDA during AI meeting for software decision support under review? Ours is an adjunctive tool, and we specify that in IFU. Even if device completely fails, the physician would just use SOC methods for diagnosis.
We submitted this 510(k) to FDA just a few days after aforementioned Act was published. As such, our predicate would now be considered unregulated. What to do?? I feel like we are caught in the middle now.
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Gretchen Upton RAC
San Antonio TX
United States
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