FDA Seeks UDI Amendment Comments

FDA Seeks UDI Amendment Comments

FDA-UDI Comment Period closes December 19, 2012

Last month FDA published an amendment to its July 10, 2012 UDI proposed rule (77 FR 40736). Section 614 of FDASIA amends the FD&C Act and moves up the dates of compliance. Comments on this amendment to the proposed rule are due by December 19, 2012.

UDI Regulations as proposed on July 10, 2012

The Food and Drug Administration Amendments Act of 2007 (FDAAA), amended the Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to promulgate regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number.

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