Industry Aims To Steer Bar Code Debate Toward Alternatives To FDA Proposal
This article was originally published in The Gray Sheet
Executive Summary
Voluntary use of automatic identification technologies should be explored in lieu of an FDA bar code labeling requirement for medical devices, industry reps say
You may also be interested in...
House Debates Medical Error Legislation Versus Self-Regulation
The House Energy & Commerce Committee has yet to decide whether to develop legislation aimed at reducing medical errors or defer to industry self-regulation
FDA Regulatory News In Brief
Device tracking: 1Medical device tracking final rule amending 1993 reg to reflect changes under FDAMA is effective May 9. No revisions are made to the April 25, 2000 proposed rule (2"The Gray Sheet" May 1, 2000, In Brief). The rule "makes no revisions to the regulation's existing system and content tracking requirements, the current obligations of persons other than device manufacturers, such as distributors, records and inspection requirements and existing record retention requirements." A final guidance on medical device tracking was issued Jan. 24, 2000...
Device Bar-Coding Advocated By GPOs; FDA Cost Analysis Awaited
FDA may decide to pursue a medical device bar-code labeling requirement independently of the rulemaking process for drugs and biologics