Modern Healthcare (07/03/12) Lee, Jaimy
The Food and Drug Administration (FDA) has released its proposed rule on unique device identifiers (UDI), which would be applicable to most medical devices distributed in the United States so that the agency can better track and collect safety data about the devices, particularly information about adverse events. Participating devices will be assigned a device identifier, which is a unique numeric or alphanumeric code for a device model, and a production identifier, which includes data such as lot or batch number, serial number or expiration date. Low-risk devices such a bedpans and other over-the-counter products will be exempted from the rule, which will mandate implementation for high-risk devices first. High-risk devices would have to have a UDI on the label and packaging within 12 months after the final rule and on the device itself within three years.