On September 24, 2013 the Food and Drug Administration ("FDA" or "the agency") published its final rule establishing the Unique Device Identification System ("UDIS") ("UDIS final rule").
The rule responds to successive statutory commands of Congress: (1) Section 226 of the Food and Drug Administration Amendments Act of 2007 ("FDAAA"); and (2) Section 614 of the Food and Drug Administration Safety and Innovation Act of 2012 ("FDASIA"). Each dealt with Section 519 (f) of the Federal Food, Drug and Cosmetic Act ("FDCA" or "the Act"). FDAAA inserted section 519 (f) to instruct the agency to "promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier...which shall adequately identify the device through distribution and use, and may include information on the lot or serial number." FDASIA subsequently amended Section 519 (f) by establishing the deadline of December 31, 2012 for the agency to propose a rule, requiring FDA to promulgate final regulations within six months of the ending of the comment period and ordering FDA to implement the system – for life saving, life sustaining and implantable medical devices – within two years of finalization.
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