Michael R. Berman

TL;DR: In this article, the authors conducted a computational interlaboratory study to determine the suitability and methodology for simulating fluid flow in an idealized medical device, which was a cylindrical nozzle with a conical collector and sudden expansion on either side of a 0.04 m long, 0.004 m diameter throat.

TL;DR: In this paper, the authors evaluate the use and limitations of computational fluid dynamics (CFD) in assessing blood flow parameters related to medical device safety, including mean velocity and turbulent flow quantities.

TL;DR: The U.S. Food and Drug Administration recently hosted an interlaboratory study to assess the suitability and methodology of computational fluid dynamics (CFD) for demonstrating medical device safety in regulatory submissions as mentioned in this paper.

TL;DR: The Department of Health and Human Services, at the direction of Congress, has recently begun to address concerns regarding the development of medical devices designed specifically for the pediatric population, including devices for pediatric mechanical circulatory support, as evidenced by the National Institutes of Health's funding of several development contracts.

TL;DR: FDA believes that clinical data used to support such safety and probable benefit may be derived from a small focused clinical trial in this target population, and developers may want to consider this approach for approval of the humanitarian device exemption application.