FDA approval

From: Follicle Boy
Date: 7/25/00
Time: 5:54:54 AM
Remote Name: 209.208.28.45

Comments

Andy,

You seem to be saying that FDA approval would not be required for this procedure because it is not chemical in nature. I do believe, however, that the FDA does need to approve all medical procedures. Certainly other tissue engineered products such as artificial skin for grafts and the treatment of chronic wounds required years of review by the FDA and even now I think only one (possibly two) has been approved for limited use. This is the case even though regular skin grafts have been done for many, many decades. I personally believe that if any of us wants this procedure performed in the US it will have to be as part of a clinical trial, at least for a year after it is introduced... or two... or three...