This is a long standing project supported by the members of AMDM who manufacture and sell media for the growth of cells. Working with Hogan & Hartson this subcommittee has met with FDA and provided FDA with written recommendations on what sort of submissions would be required in order to get FDA clearance for the sale of cell culture products for clinical ex vivo cell cultures procedures.

Since the start of this project in 1995 there has been little apparent progress on the part of FDA. The issue currently resides with Susan Alpert in the Center for Devices. Hogan & Hartson again approached FDA this past fall asking what the status of this project was and whether it would be possible to schedule another meeting in light of the various new laws affecting the classification of medical devices.

Susan Alpert noted the ball was in her court and that follow-up had been lacking. She promised to resurrect the project within FDA and get back to AMDM with recommendations for the next step. There has been correspondence to date.