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Gail Javitt Quoted in “FDA’s Regulation of CDS Software: Will Physicians Have to Understand the Underlying Algorithms?”

Regulatory Affairs Professionals Society (RAPS)

Gail H. Javitt, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Regulatory Affairs Professionals Society (RAPS), in “FDA’s Regulation of CDS Software: Will Physicians Have to Understand the Underlying Algorithms?” by Zachary Brennan.

Following is an excerpt:

A key section of the recently passed 21st Century Cures Act explained to the US Food and Drug Administration (FDA) which categories of software should be exempt from medical device regulations.

Most of these newly excluded categories involve relatively harmless billing or scheduling software, software for encouraging a healthy lifestyle, or even electronic health record (EHR) or Medical Device Data System (MDDS) software, as long as they don’t interpret or analyze the data for the purpose of “diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.” …

According to Gail Javitt, a lawyer for Epstein Becker and Green, FDA generally considers CDS software that “do not direct a specific clinical decision to pose less risk than those that will be used as the sole basis for decision making or that provide directive clinical recommendations.”

But those lines are beginning to blur.

As Javitt notes, “For example, in the case of computer-aided detection (CAD) devices used in conjunction with breast imaging, FDA distinguishes between those that are intended solely to direct the clinician’s attention to portions of an image or aspects of radiology device data (CADe) and those that also are intended to assess disease risk, specify disease type, severity, or stage and/or recommend an intervention (CADx). Whereas CADe devices generally are class II (moderate risk), CADx devices are class III (high risk).”