Devices

CDRH Begins Standardizing Medical Device Evaluation

The Case for Quality, a collaboration between FDA, the medical device industry, healthcare providers, and quality experts, is examining the feasibility and effectiveness of using standardized medical device performance data and analytic techniques to help hospitals better compare and evaluate product quality. The multi-year Case for Quality initiative is intended to develop best practices, standards, tools, and metrics that can be used by both the agency and industry to improve product and manufacturing quality in ways that go beyond compliance with regulatory requirements. It is being coordinated by the Medical Device Innovation Consortium, the first public-private partnership between FDA, industry, and other collaborators to advance medical device regulatory science.

The Case for Quality’s Product Quality Analytics Working Group conducted a pilot with seven hospitals on knee implants and implantable cardioverter defibrillators. Data were collected from several sources on seven quality parameters — safety, effectiveness, reliability, usability, compatibility, patient experience, and availability. The data were analyzed to calculate key performance indicators, which were presented to hospital value analysis committees in four quality dashboards that contained an overview and rankings by data source, manufacturer, and product.

The group’s Outcomes Analytics report says the three significant challenges to accurate and complete data on medical device quality are (1) lack of unbiased, relevant, consistent, and available data; (2) lack of consistently defined device quality dimensions, or applied analytical methods; and (3) lack of secure process and operating model to build stakeholder confidence and enable individual companies to be fully transparent about product quality.

The report includes recommendations such as a need to improve data robustness and a need to develop an operating model that would enable data access and transparency for scale and sustainability in the future.

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

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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