H.R. 3580: Food and Drug Administration Amendments Act of 2007
Subtitle B–Amendments Regarding Regulation of Medical Devices
Unique Device Identifier System
(f) The Secretary shall promulgate regulations establishing a unique device identifier 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)’.
SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES.
Subparagraph (B) of section 519(a)(1) (21 U.S.C. 360i(a)(1)) is amended by striking `were to recur;’ and inserting the following: `were to recur, which report under this subparagraph–
(i) shall be submitted in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations), unless the Secretary grants an exemption or variance from, or an alternative to, a requirement under such regulations pursuant to section 803.19 of such part, if the device involved is–
(I) a class III device;
(II) a class II device that is permanently implantable, is life supporting, or is life sustaining; or
(III) a type of device which the Secretary has, by notice published in the Federal Register or letter to the person who is the manufacturer or importer of the device, indicated should be subject to such part 803 in order to protect the public health;
(ii) shall, if the device is not subject to clause (i), be submitted in accordance with criteria established by the Secretary for reports made pursuant to this clause, which criteria shall require the reports to be in summary form and made on a quarterly basis; or
(iii) shall, if the device is imported into the United States and for which part 803 of title 21, Code of Federal Regulations (or successor regulations) requires an importer to submit a report to the manufacturer, be submitted by the importer to the manufacturer in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations)’.