From: Zorina Pitkin [zpitkin@nephrostherapeutics.com]
Sent: Friday, November 08, 2002 5:06 PM
To: fdadockets@oc.fda.gov
Cc: Mark Kramer (E-mail)
Subject: FDA Regulation of Combination Products; Public Hearing

Reference is made to Federal Register/Vol.67, No 208 of October 28, 2002, Docket No.02N-0445, regarding FDA's Public Hearing on Regulation of Combination Products.

On behalf of Nephros Therapeutics, Inc., I would like to present our comments regarding questions 2-5 posed in the Federal Registry. We estimate a 10-minute presentation that will cover the prospective of a technology where cell therapy is being delivered via a device component.

Thank you very much for your consideration.

Sincerely,

Zorina Pitkin, Ph.D., RAC
Vice President, Regulatory Affairs and Quality Systems
Nephros Therapeutics, Inc.
Six Court Drive
Lincoln, RI 02865
Telephone: 401 333 3789, ext. 224
Fax: 401 333 3774
e-mail: zpitkin@nephrostherapeutics.com