Sec. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES
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## SEC. 704 CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES Subsection (e)(4) of section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is amended— ####
(1)by adding at the end the following: > > ##### “(E) > > > ######
(i)> > > ######
(I)> > If the Secretary denies a request for certification under subparagraph (A)(ii) with respect to a device manufactured in an establishment (foreign or domestic) registered under section 510, the Secretary shall provide in writing to the person seeking such certification the basis for such denial, and specifically identify the finding upon which such denial is based. > > > ###### “(II) > > If the denial of a request as described in subclause
(I)is based on grounds other than an injunction proceeding pursuant to section 302, seizure action pursuant to section 304, or a recall designated Class I or Class II pursuant to part 7, title 21, Code of Federal Regulations, and is based on the facility being out of compliance with part 820 of title 21, Code of Federal Regulations, the Secretary shall provide a substantive summary of the specific grounds for noncompliance identified by the Secretary. > > > ###### “(III) > > With respect to a device manufactured in an establishment that has received a report under section 704(b), the Secretary shall not deny a request for certification as described in subclause
(I)with respect to a device based solely on the issuance of that report if the owner, operator, or agent in charge of such establishment has agreed to a plan of correction in response to such report. > > > ###### “(ii) > > > ######
(I)> > The Secretary shall provide a process for a person who is denied a certification as described in clause (i)(I) to request a review that conforms to the standards of section 517A(b). > > > ###### “(II) > > Notwithstanding any previous review conducted pursuant to subclause (I), a person who has been denied a certification as described in clause (i)(I) may at any time request a review in order to present new information relating to actions taken by such person to address the reasons identified by the Secretary for the denial of certification, including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by the Secretary. > > > ###### “(III) > > Not later than 1 year after the date of enactment of the FDA Reauthorization Act of 2017, the Secretary shall issue guidance providing for a process to carry out this subparagraph. Not later than 1 year after the close of the comment period for such guidance, the Secretary shall issue final guidance. > > > ###### “(iii) > > > ######
(I)> > Subject to subclause (II), this subparagraph applies to requests for certification on behalf of any device establishment registered under section 510, whether the establishment is located inside or outside of the United States, and regardless of whether such devices are to be exported from the United States. > > > ###### “(II) > > If an establishment described in subclause
(I)is not located within the United States and does not demonstrate that the devices manufactured, prepared, propagated, compounded, or processed at such establishment are to be exported from the United States, this subparagraph shall apply only if— > > > ###### “(aa) > > the establishment has been inspected by the Secretary within 3 years of the date of the request; or > > > ###### “(bb) > > the establishment participates in an audit program in which the United States participates or the United States recognizes, an audit under such program has been conducted, and the findings of such audit are provided to the Secretary within 3 years of the date of the request.” > ; and ####
(2)by moving the margins of subparagraphs
(C)and
(D)4 ems to the left.
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Sec. 704
CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES
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