The amendment shortens the originally proposed compliance deadline. Under the amendment, all implantable devices must include a UDI within two years after publication of the final rule.
The FDA said the shortened compliance period was required by the Food and Drug Administration Safety and Innovation Act of July 2012.
More Articles on a UDI System:
FDA’s Unique Device Identification Rule Represents Progress, but Quicker Changes Needed
FDA Proposes Identification System for Medical Devices
Congress Passes FDA Safety and Innovation Act With Drug Shortage Provisions
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