The Food and Drug Administration has published amendments to the proposed rule issued in July 2012 to establish a unique identifier for medical devices.
The comment period for the proposed rule closed on Nov. 7 and FDA received multiple requests to speed up the proposed implementation plan, which in some areas stretched out to seven years. Under the amendments, some timetables are reduced, with implantable devices having to bear a unique device identifier as a permanent marking on the device either one, three or five years earlier than first proposed, depending on the device.
The amendments include an updated table showing effective dates of a number of UDI regulatory requirements. Comments on the amendments are due on Dec. 19. The amendments, published Nov. 19 in the Federal Register, are available here.
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