Devices

Clinical Decision Support Software Makers Seek ‘Regulatory Clarity’

The Clinical Decision Support Coalition says FDA is not providing “regulatory clarity” on clinical decision support (CDS) software. A 2/25 white paper from the group says that the agency had identified CDS software guidance a top priority in its 2015 regulatory agenda, but the agency has yet to define the “portion of CDS software it intends to regulate and, for that portion it does regulate, the appropriate regulatory pathway to market..

CDS software, which analyzes clinical and nonclinical data to guide health care decision-making, has the potential to drive significant improvements in health care quality and efficiency, the coalition says. “Of course, developing a regulatory framework for CDS software is no easy task, as FDA must strike a delicate balance between ensuring patient safety and promoting innovation,” the paper says. “However, until a regulatory approach is defined, CDS innovators will be left in the dark with regard to the expected costs and timelines for CDS development. Such uncertainty has already contributed to delays in CDS products reaching the market and, worse yet, the abandonment of CDS development projects altogether.”

The paper notes that a recent survey of CDS developers found that nearly two thirds reported encountering delays due to regulatory uncertainty, and one third reported that regulatory uncertainty caused them to abandon CDS product development. “Without clear regulatory guidance on which CDS products will be regulated and, for those that are, how such products will be regulated, valuable CDS tools, which can improve health outcomes, enhance the quality and consistency of care, and increase efficiency, will be kept out of the hands of clinicians and patients.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

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