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Brendon Nafziger, DOTmed News Associate Editor | November 09, 2012
"During, or just prior to, surgical implantation of the device the UDI is entered into the patient's EHR providing a permanent link between the patient and the implanted device," the group said in its comments. "This information will be available to all those who are authorized to access the patient's EHR and will not require a surgical procedure to extract the device and scan the UDI. Postmarket surveillance is conducted non-invasively on EHRs databases."
Under the FDA user fee renewal bill, final UDI rules would have to be issued within six months of ending the comment period — that is, in May.
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