2006N-0292 Unique Device Identification
FDA Comment Number : EC25
Submitter : Ms. Beverly Thomas Date & Time: 10/05/2006 09:10:12
Organization : Department of Health, Medical Qaulity Assurance Co
Category : State Government
Issue Areas/Comments
Implementing Unique Device Identifiers
Should a UDI be based on the use of a specific technology
Yes, I believe there is a significant problem for state board to regulate who can use medical devices. Such as the lasers, it has become very apparent that prescritive medical devices are being sold to individuals without having prescriptive authority and are harming patients. Identification of the classification would be easier State board investigators or inspectors if each devices had a UDI.