Nephros, a medical device company developing and marketing filtration products for therapeutic applications, infection control and water purification, has reported that the FDA has issued a formal response to its 510(k) application for the company's hemodiafiltration (HDF) system.
Reportedly, on June 30, Nephros had received FDA final decision letter for the company’s 510(k) submission which stated that the FDA could not reach a substantial equivalence determination for the company’s hemodiafiltration (HDF) system.
Paul Mieyal, acting CEO of Nephros, said: “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.
“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.”
Lawrence Centella, a member of board of directors and former chief operating officer of Gambro Healthcarea at Nephros, said: “Outside of the US, 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 US has been further delayed.”