REPORTS.

SEC. 213. REPORTS. (a) Reports.—Section 519 (21 U.S.C. 360i) is amended— (1) in subsection (a)— (A) in the matter preceding paragraph (1), by striking “manufacturer, importer, or distributor” and inserting “manufacturer or importer”; (B) in paragraph (4), by striking “manufacturer, importer, or distributor” and inserting “manufacturer or importer”; 111 STAT. 2347 (C) in paragraph (7), by adding “and” after the semicolon at the end; (D) in paragraph (8)— (i) by striking “manufacturer, importer, or distributor” each place such term appears and inserting “manufacturer or importer”; and (ii) by striking the semicolon at the end and inserting a period; (E) by striking paragraph (9); and (F) by inserting at the end the following sentence: “The Secretary shall by regulation require distributors to keep records and make such records available to the Secretary upon request. Paragraphs (4) and (8) apply to distributors to the same extent and in the same manner as such paragraphs apply to manufacturers and importers.”; (2) by striking subsection (d); and (3) in subsection (f), by striking “, importer, or distributor” each place it appears and inserting “or importer”. (b) Registration.—Section 510(g) (21 U.S.C. 360(g)) is amended— (1) by redesignating paragraph (4) as paragraph (5); (2) by inserting after paragraph (3) the following: “(4) any distributor who acts as a wholesale distributor of devices, and who does not manufacture, repackage, process, or relabel a device; or”; and (3) by adding at the end the following flush sentence: “In this subsection, the term ‘wholesale distributor’ means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.”. (c) Device User Facilities.— (1) In general.—Section 519(b) (21 U.S.C. 360i(b)) is amended— (A) in paragraph (1)(C)— (i) in the first sentence, by striking “a semi-annual basis” and inserting “an annual basis”; (ii) in the second sentence, by striking “and July 1”; and (iii) by striking the matter after and below clause (iv); and (B) in paragraph (2)— (i) in subparagraph (A), by inserting “or” after the comma at the end; (ii) in subparagraph (B), by striking “, or” at the end and inserting a period; and (iii) by striking subparagraph (C). (2) Sentinel system.—Section 519(b) (21 U.S.C. 360i(b)) is amended— (A) by redesignating paragraph (5) as paragraph (6); and (B) by inserting after paragraph (4) the following paragraph: “(5) With respect to device user facilities: “(A) The Secretary shall by regulation plan and implement a program under which the Secretary limits user reporting 111 STAT. 2348under paragraphs (1) through (4) to a subset of user facilities that constitutes a representative profile of user reports for device deaths and serious illnesses or serious injuries. “(B) During the period of planning the program under subparagraph (A), paragraphs (1) through (4) continue to apply. “(C) During the period in which the Secretary is providing for a transition to the full implementation of the program, paragraphs (1) through (4) apply except to the extent that the Secretary determines otherwise. “(D) On and after the date on which the program is fully implemented, paragraphs (1) through (4) do not apply to a user facility unless the facility is included in the subset referred to in subparagraph (A). “(E) Not later than 2 years after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall submit to the Committee on Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the plan developed by the Secretary under subparagraph (A) and the progress that has been made toward the implementation of the plan.”.