FDA releases proposed UDI rules

by Brendon Nafziger, DOTmed News Associate Editor | July 03, 2012

However, she did make one strong criticism, saying the timeline was too long, and might conflict with Congress' requirement, in the recent FDA user fee act, that the system be up for at least implantable devices within two years of the rule being finalized.

"Since we have already been waiting five years for UDI, patients can’t wait until 2019 to have confidence that the devices implanted in their bodies are safe and effective," she said in a statement.

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(23) (3) (14) (38) John Weymouth This is a good thing and it will cost money in the short term. July 05, 2012 12:49 It will cost manufacturers money to redo the labels. The benefit to the industry, patients and reducing the cost of investigations is the real plus. It should take 2 months for the redesign, approval and implementation of the labels. An additional label that would reduce the redesign time-frame may be an option. Reused items may be the bigger problem with injection molds. Metal devices could be acid etched or yag laser marked. Manufactures need to get started or if they were on top if issues, they have had 5 years to think of options. john@medisurg.com Log inor Register to rate and post a comment
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