UNIQUE DEVICE IDENTIFICATION SYSTEM.

SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM.(a) In General.—Section 519 (21 U.S.C. 360i) is amended—(1) by redesignating subsection (f) as subsection (g); and(2) by inserting after subsection (e) the following:“Unique Device Identification System“(f) The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.”.(b) Conforming Amendment.—Section 303 (21 U.S.C. 333) is amended—(1) by redesignating the subsection that follows subsection (e) as subsection (f); and(2) in paragraph (1)(B)(ii) of subsection (f), as so redesignated, by striking “519(f)” and inserting “519(g)”.