Report of Telephone Conversation
Date/Time of Call: September 7, 2012
Representative: Randa Melhem, Ph.D., OCBQ/DMPQ, HFM-676
Representative: Jessica Chung, Associate Director, Regulatory Affairs
Organization: Ethicon Inc.
Subject: Information Request – Follow up on the August 2, 2012 Telecon
During the August 2, 2012 Telecon, Ethicon clarified in response to comment 6 regarding the clean and sterile/sanitized hold time for equipment at FPPF, that they have initiated an SPR to perform studies to support 24 hour CEHT and SEHT which will be completed during this month (August) and sent to FDA.
I called Ms. Jessica Chung and requested that Ethicon submit the results of the CEHT and SEHT studies referred to in the August 2, 2012 telecon. She said they have the data and would submit to FDA within few days.