November 21, 2014

FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants

From: Regulatory Affairs Professional Society

By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is granting labelers of certain types of implantable medical devices a temporary reprieve from its upcoming requirements that all medical device products be marked with a unique device identifier (UDI) meant to make the devices safer.


The rule was originally mandated by the Food and Drug Administration Amendments Act (FDAAA) of 2007, but was subject to lengthy delays, both due to extensive rewrites resulting from industry criticism and months of review by the Office of Management and Budget (OMB).

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