Industry Puzzles Over FDA’s Updated Guidance on Clinical Decision Support Software

The FDA’s attempt to clarify its draft guidance on clinical decision support (CDS) software raised new questions, devicemakers said in written comments to the agency.

In an updated draft guidance on Sept. 27, 2019 the agency clarified that software functions that treat or diagnose are not CDS, as defined in the Cures Act, because they go beyond supporting or providing recommendations to a healthcare professional, patient, or caregiver.

AdvaMed said the guidance helped clarify the types of software that are subject to FDA oversight, but it said the agency should issue additional guidance describing how it will regulate CDS.

ResMed said the agency should clarify how it will apply the International Medical Device Regulators Forum approach for CDS software functions. As drafted, the guidance “creates confusion about the respective authority of the statutory criteria and the IMDRF factors,” the company said.