Clinical Decision Support Software: Stakeholders Seek More Clarity From FDA Draft Guidance

Regulatory NewsRegulatory News | 16 January 2020 |  By 

Industry groups, the Mayo Clinic, Regeneron and others are seeking more clarity from the US Food and Drug Administration’s (FDA) revised draft guidance on clinical decision support (CDS) software.

The 27-page draft from September builds on a previous draft from 2017, with which industry also raised concerns. The latest draft clarifies the categories of CDS software subject to FDA oversight, as well as the low-risk categories of CDS software for which FDA does not intend to enforce regulatory requirements and CDS categories that do not meet the definition of a device.

Weighing in on the draft, industry group AdvaMed praised its discussions of what types of software are, or are not, subject to FDA’s oversight. But the group also called on FDA to include a flowchart or other visual aid to help in understanding the regulatory status of a particular product.

Similarly, the Medical Imaging & Technology Alliance (MITA) said that, “Given the complexity of the determination process (level of significance, intended user, ability to review the basis of recommendation), we recommend that a flowchart be created. It would help the reader understand what are the key elements to consider when assessing whether a SaMD [software as a medical device] is a Non-Device CDS or not.”

MITA also sought further refinement of the definitions of "(1) treat or diagnose, (2) drive, (3) inform" to “drive consistency in interpretation. We suggest that FDA clarifies the extent to which the information provided by the SaMD and the intended user each contribute to the decision-making process across the three levels of significance.”

In addition, the Duke Margolis Center for Health Policy said the guidance is “vague on how manufacturers could evaluate their products,” regarding the difference between “inform” and “drive.” The center also seeks examples from FDA that focus on devices that are not CDS solely because the software “drives” clinical management versus “informs.”

The Mayo Clinic similarly sought clarification from FDA on informs vs. drives, noting that the difference between “informing clinical management” and “driving clinical management” will mean “the difference between being subject to the FDA regulation and meeting the definition of a medical device. This is especially problematic in the area of laboratory testing.” Mayo added that it’s is unclear on how “inform” and “drive” differ when it comes to aggregating clinical information for laboratory testing.

Biopharma company Regeneron, meanwhile, sought further clarity on if software used in a clinical trial to support clinical decisions needs to follow the guidance, or if the recommendations are solely for CDS intended for commercial use.

“It remains unclear what regulatory recommendations should be considered when using CDS that is not 510K cleared in a clinical trial and when the use is for a critical or serious condition. The draft guidance does not discuss whether the use of CDS in companion diagnostic (CDx) studies is in scope, which therefore presents an opportunity to expand on commensurate recommendations for Sponsors and device manufacturers,” Regeneron said.



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