Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Hako-Med petition: Honolulu firm's April 23 petition requesting that low-voltage electrode lead wires in the vacuum hose of the VacuPulls/VasoPulse be exempted from the performance standard for electrode lead wires and patient cables (21 CFR 898) is denied by FDA. "In this instance, the public health derives no benefit from the continued use of non-compliant electrode lead wires that is not already provided by equivalent powered muscle stimulator and powered peripheral nerve stimulator devices that use compliant electrode wires," the agency writes in the Aug. 30 denial letter. "The continued marketing of unprotected electrode leads and patient cables, no matter how they are labeled, presents an unreasonable and substantial risk of illness or injury to individuals"...
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DES deemed model for FDA/CMS collaboration: CMS Administrator Mark McClellan, MD/PhD, is "very interested" in creating a faster pathway to market for promising new devices and drugs by better coordinating the approval and reimbursement processes at FDA and CMS. "A great model going forward for important new technologies" is mirroring "the work that we did jointly on drug-eluting stents where - with the manufacturers' support - our FDA staff was able to share the information we were using for the product approval decisions with CMS so that when FDA made its approval decision, the coverage codes and coverage for that treatment came right away," he explained at the Food & Drug Law Institute Annual Meeting April 15 in Washington, D.C...