Page:United States Statutes at Large Volume 121.djvu/876

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 855

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)’’. SEC. 228. INSPECTIONS BY ACCREDITED PERSONS.

dkrause on GSDDPC44 with PUBLAW

Section 704(g) (21 U.S.C. 374(g)) is amended— (1) in paragraph (1), by striking ‘‘Not later than one year after the date of the enactment of this subsection, the Secretary’’ and inserting ‘‘The Secretary’’; (2) in paragraph (2), by— (A) striking ‘‘Not later than 180 days after the date of enactment of this subsection, the Secretary’’ and inserting ‘‘The Secretary’’; and (B) striking the fifth sentence; (3) in paragraph (3), by adding at the end the following: ‘‘(F) Such person shall notify the Secretary of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems standard referred to in paragraph (7) for any device establishment that such person inspects under this subsection not later than 30 days after such withdrawal, suspension, restriction, or expiration. ‘‘(G) Such person may conduct audits to establish conformance with the quality systems standard referred to in paragraph (7).’’; (4) by amending paragraph (6) to read as follows: ‘‘(6)(A) Subject to subparagraphs (B) and (C), a device establishment is eligible for inspection by persons accredited under paragraph (2) if the following conditions are met: ‘‘(i) The Secretary classified the results of the most recent inspection of the establishment as ‘no action indicated’ or ‘voluntary action indicated’. ‘‘(ii) With respect to inspections of the establishment to be conducted by an accredited person, the owner or operator of the establishment submits to the Secretary a notice that— ‘‘(I) provides the date of the last inspection of the establishment by the Secretary and the classification of that inspection; ‘‘(II) states the intention of the owner or operator to use an accredited person to conduct inspections of the establishment; ‘‘(III) identifies the particular accredited person the owner or operator intends to select to conduct such inspections; and

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