Friday, July 13, 2012

BILL S,3187 SEC. 614. UNIQUE DEVICE IDENTIFIER


SEC. 614. UNIQUE DEVICE IDENTIFIER.
Section 519(f) (21 U.S.C. 360i(f)) is amended—
(1) by striking ‘‘The Secretary shall promulgate’’ and
inserting ‘‘Not later than December 31, 2012, the Secretary
shall issue proposed’’; and
(2) by adding at the end the following: ‘‘The Secretary
shall finalize the proposed regulations not later than 6 months
after the close of the comment period and shall implement
the final regulations with respect to devices that are
implantable, life-saving, and life sustaining not later than 2
years after the regulations are finalized, taking into account
patient access to medical devices and therapies.’’.

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