FDA Extends Regulatory Reach to Low-Risk CDS Software

Health Data Management

Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in Health Data Management, titled “FDA Extends Regulatory Reach to Low-Risk CDS Software.”

Following is an excerpt:

Historically, the Food and Drug Administration hasn’t regulated most clinical decision support software. But it might be time for developers of this type of software to start paying attention to the FDA, because that’s likely going to change.

In a surprise move, the FDA published a draft guidance in December that would regulate essentially all CDS software, unless it meets special requirements of the 21st Century Cures Act.

According to the 21st Century Cures Act, CDS software is exempt from FDA regulation if the software enables a professional user “to independently review the basis for” any recommendations the software presents so that the user does not need to rely primarily” on the recommendations.

If CDS fails to do that, FDA’s guidance suggests the software becomes FDA regulated almost without exception. That’s true even if the software advises the physician of the typical symptoms of the common cold. It would seem that, for the FDA, no risk is too small to be regulated.