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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

CDRH director's plea to industry: Device center director Dan Schultz urges companies submitting complementary applications to CDRH to "get together and share information between themselves" in order to facilitate the review process. During a recent Food & Drug Law Institute meeting, he recalled FDA's review of Amplichip, which consisted of separate applications submitted by Roche and Affymetrix. Schultz noted: "One of the things that made this a little bit challenging for us was that those two companies really weren't talking to each other very much and we had to review the two separate applications essentially separately and sort of put them together ourselves and try to make sure that we had them cleared at roughly the same time." He added: "Recognizing that we are going to be seeing more and more of these products come in as combinations or as products that are being used together, the extent that industry can get together and share information between themselves...and share it with us, would really make our lives a lot easier"...

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Regulatory News In Brief

AbioCor HDE: Review of Abiomed's total artificial heart humanitarian use exemption (HDE) application is challenging the agency to consider how much weight should be given to the probable benefit of devices when adverse event risks are significant. On June 23, an FDA panel narrowly voted (7-6-1) that the artificial heart failed to meet criteria for HDE approval (1"The Gray Sheet" June 27, 2005, p. 5). However, FDA is signaling that it will look at more than the final panel vote in judging whether to approve the HDE. Potential artificial heart users "are at the end of their life. They don't have any other alternatives, and for them, maybe the chance to live another couple of months is worth the risks from the adverse events that the device presents," CDRH Office of Device Evaluation Director Donna Bea Tillman said June 28 during a conference on AAMI Human Factors, Ergonomics and Patient Safety for Medical Devices in Washington, D.C. "Trying to make that balance, I think, is something that continues to be a real challenge," the ODE official added...

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