Devices

Input on Non-Device Software Functions

Three stakeholders have submitted information in response to an FDA renewed solicitation for public input on patient safety, including best practices to promote patient safety, education, and competency, associated with medical software functions that are excluded from the medical device definition in the 21st Century Cures Act. Wolters Kluwer cites the “substantial benefit to patients that accrues from clinician use of non-device CDS (clinical decision support), including evidence-based clinical knowledge systems.” The clinical technology firm stresses the need for CDS content to be created by a multidisciplinary team of clinical experts with the background and experience needed to curate such content. The team should be able to assess the medical evidence using a formal grading methodology, it says, and should review content regularly and update it as new evidence dictates.

The Digital Medicine Society says FDA should place a greater focus on the usability of and trust in the non-device software functions in an upcoming agency report. “The forthcoming publication should more strongly feature the impact that product risks and benefits have on product usability and trust, it says.

In its submission, the American College of Cardiology discusses the use of non-device software in the administrative support of healthcare facilities, maintaining or encouraging a healthy lifestyle, and certain clinical decision support and provides citations to journal articles on aspects of the three areas of concern.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome