RIVER EDGE, N.J.—In a June 30 letter to Nephros, the U.S. Food and Drug Administration said it “could not reach a substantial equivalence determination for the company's hemodiafiltration (HDF) system” in regards to its 510(k) application.
"We are disappointed both by the FDA's decision to reject our application and by the fact that the company was not provided an opportunity to address the current comments prior to a final decision being rendered," said Paul A. Mieyal, acting CEO of Nephros. "After more than 15 months without a substantive communication, the company expected either an approval or further dialogue as the next step in the process. We feel that the issues raised in the current letter are addressable and have requested an in-person meeting with the review team to discuss options for moving forward."
In response to the letter, Nephros has requested an in-person meeting to discuss the issues raised in the current FDA letter as well as the process for moving forward.
"Outside of the United States, hemodiafiltration is widely regarded by nephrologists as the gold standard therapy for dialysis patients. We are disappointed that the availability of HDF therapy in the U.S. has been further delayed," commented Lawrence J. Centella, a member of Nephros's board of directors and former chief operating officer of Gambro Healthcare, Inc.
Based upon the in-person meeting with the FDA reviewers, Nephros said it will determine the appropriate course of action, which could include filing a new 510(k) application or filing an appeal related to the current application.
Nephros has worked with King & Spalding LLP as regulatory counsel to advise the company in its next interactions with the FDA. The company said it also intends to utilize the FDA's Ombudsman process.
The company added that the current decision by the FDA does not impact the ability of the company to market and sell its mid-dilution (MD) filters for hemodiafiltration procedures outside of the United States.