Sec. 701. RISK-BASED INSPECTIONS FOR DEVICES
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## SEC. 701 RISK-BASED INSPECTIONS FOR DEVICES ###
(a)In general Section 510(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)) is amended— ####
(1)by striking paragraph
(2)and inserting the following: > > #### “(2) Risk-based schedule for devices > > > ##### “(A) In general > > The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph
(1)that are engaged in the manufacture, propagation, compounding, or processing of a device or devices (referred to in this subsection as ‘device establishments’) in accordance with a risk-based schedule established by the Secretary. > > > ##### “(B) Factors and considerations > > In establishing the risk-based schedule under subparagraph (A), the Secretary shall— > > > ###### “(i) > > apply, to the extent applicable for device establishments, the factors identified in paragraph (4); and > > > ###### “(ii) > > consider the participation of the device establishment, as applicable, in international device audit programs in which the United States participates or the United States recognizes for purposes of inspecting device establishments.” > ; and ####
(2)in paragraph (4)— #####
(A)in the matter preceding subparagraph (A), by striking “paragraph (3)” and inserting “paragraph
(2)or (3)”; and #####
(B)in subparagraph (C), by inserting “or device” after “drug”. ###
(b)Foreign Inspections Section 809(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended by striking “section 510(h)(3)” and inserting “paragraph
(2)or
(3)of section 510(h)”.
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