Device bar coding
This article was originally published in The Gray Sheet
Executive Summary
FDA remains receptive to industry concerns about the logistics of requiring bar codes for devices, according to agency staff. Obstacles include product diversity and the lack of a unique identification system comparable to the National Drug Code (NDC). Views on the topic likely differ across FDA; CBER, for example, was not included in an April 13-14 FDA/industry meeting to consider device bar-coding and alternatives such as radiofrequency tags (1"The Gray Sheet" April 22, 2005, p. 6). FDA may decide on the matter shortly; in a FDL-1May 9 letter, hospital associations join group purchasing organization Premier in urging the agency to add devices to products for which bar coding is required under a February 2004 rule. The letter follows a similar one from Rep. Pete Sessions (R-Texas) to the agency. FDA staff registered surprise at the second letter, since most of the signatories were present at the April meeting...