FDA medical device ID program: Purchasers pleased, industry wary

Thu, 07/05/2012 - 1:02pm
Mass Device

Group purchasing organization Novation applauds the FDA's proposed unique device identifier program, but med-tech industry lobbying group AdvaMed wants to take a closer look to ensure the program avoid unnecessary burdens.

FDA UDI example

The FDA's UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration.

Medical tech industry stakeholders are showing mixed reactions to the FDA's latest proposal for a system of unique device identifiers that can monitor medical devices for tracking and public health purposes.

Group purchasing organization Novation applauded the FDA's effort, calling it a "significant milestone for patient safety," but representatives at industry lobby AdvaMed are taking a wary approach.

"We are reviewing the details of the proposed UDI rule and, after consultation with our members, will be submitting detailed comments," AdvaMed spokeswoman Wanda Moebius told reporters.


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