On September 27, 2022, FDA releases a number of guidances for the device and software industries, including an important guidance on when "Clinical Decision Support" software crosses the line between "Non device functions" not regulated by FDA, and "Device functions" which ARE regulated by FDA.
- See the FDA 26pp guidance here.
- See story at Stat, including the headline:
- "FDA says AI tools to warn of sepsis should be regulated as devices."
- See a tweet on this by Tim Sweeney, CEO of Inflammatix.
- See a review of several of the guidances from FDA, at PharmaPhorum here.
- Also discusses "Pre Cert" program for software.
- Foley-Lardner viewpoint at JD Supra here. A longer article, also from Foley Lardner, at JD Supra here.
- BioWorld says that leading FDA expert Brad Thompson at Epstein Becker dislikes some features of the final guidance. See his opinion in more detail ("disaster!") at RAPS open access here.
- Thompson remarks: “FDA clearly wants to block what Congress has done, to the point where it is reaching nonsensical conclusions about what statutory language means.”
- Software does not analyze/process a medical image or lab test pattern;
- The purpose is [just] displaying or analyzing medical information about the patient including clinical practice guidelines;
- Provides the health care professional with [just] "support or recommendations" for diagnosis and treatment;
- HCP independently reviews the recommendation, its basis, and does not "rely" on the software for diagnosis or treatment decisions.
Besides the 4 rules, and their subsequent discussion, FDA provides several pages of fictional examples of software that DOES, or DOES NOT, fit into the exemptions from review. FDA in particular elaborates on its requirement that the HCP "reviews the recommendation" and does not "rely."