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Nephros 510(k) woes

This article was originally published in The Gray Sheet

Executive Summary

Kidney dialysis product maker plans to meet with FDA to discuss next steps after the agency rejected a 510(k) pre-market submission for the firm's hemodiafiltration (HDF) system, designed to improve quality of life in end-stage renal disease (ESRD) patients. FDA sent a not-substantially-equivalent decision letter to the firm June 30, but Nephros says it had no opportunity to address the agency's questions before the decision was rendered. "We feel that the issues raised in the current letter are addressable," the company said July 7. According to the firm, the HDF system removes harmful substances from patients' blood "more effectively, and with greater capacity, than existing ESRD treatment methods." After meeting with FDA, Nephros plans to file a new 510(k) or appeal the current decision

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