Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “Clinical Decision Support Software Guidance Kicked Off FDA’s Priority List,” by Bronwyn Mixter.
Following is an excerpt:
In order to be regulated by the FDA, “CDS software must not be transparent,” meaning “the doctor user cannot see through the software to the underlying patient data and the clinical logic applied by the software, such that the physician is not required to rely on the software,” Thompson said.
“It’s our understanding that FDA planned to publish a guidance document stratifying CDS based on risk, and explaining where the agency draws the line between regulated and unregulated,” Thompson said. “We still need that for any software that doesn’t qualify as transparent.”
Thompson said “now, in light of the statute, we would like to understand how FDA plans to enforce the transparency concept.” He said “the statute is very helpful, but it will be very important for FDA to express the agency’s views on how the language is to be interpreted and applied.”