FDA publishes a revised UDI proposed rule

FDA publishes a revised UDI proposed rule

On November 19, 2012, FDA published a revised UDI proposed rule to accommodate the enactment of FDASIA, which was signed into law (Pub. L. 112–144) on July 9, 2012. Specifically, pursuant to FDASIA, the purpose of the revised UDI proposed rule is to specify the date by which a proposed rule is required, to identify particular devices as requiring expedited implementation of UDI requirements, and to specify timeframes for publication of a final rule.

Write a Reply or Comment