Sec. 604. Certificates to foreign governments for devices
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Subsection (e)(4) of section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(e)(4) ) is amended— by adding at the end the following: If the Secretary denies a request made under subparagraph (A)(ii) for certification with respect to a device, 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. If the denial of a request as described in clause
(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 an establishment being considered out of compliance with part 820, title 21, Code of Federal Regulations, the Secretary shall provide a substantive summary of the specific grounds for noncompliance so identified, if such grounds have not been previously communicated to the manufacturer. 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 under subparagraph (A)(ii) based exclusively 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. The Secretary shall provide a process for a person who is denied a certification as described in subparagraph (E)(i) to request a review that conforms to the standards of section 517A(b). Notwithstanding any previous review conducted pursuant to clause (i), a person who has been denied a certification for a device as described in subparagraph (E)(i) may, at any time, request a review of that denial in order to present new information relating to actions taken by such person to address the reasons identified by the Secretary for such denial, including evidence that corrective actions are being or have been implemented to address the grounds for noncompliance identified by the Secretary under subparagraph (E)(ii). This paragraph applies to requests for certification on behalf of any device establishment registered under section 510, whether the establishment is located in the United States or another country. The Secretary may charge a fee for the issuance of a certification described in clause (i), and such fee is subject to the same conditions and requirements as a fee charged under subparagraph
(B)for a certification issued under such subparagraph. ; and by moving the margins of subparagraphs
(C)and
(D)4 ems to the left. Not later than 1 year after date of the enactment of this section, the Secretary of Health and Human Services shall issue guidance providing for a process to carry out subparagraph
(F)of section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(e)(4) ), as added by subsection (a). Not later than 12 months after the comment period closes for the draft guidance, the Secretary shall issue final guidance.
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Sec. 604
Certificates to foreign governments for devices
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