Sec. 701. Risk-based inspections for devices
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Section 510(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(h) ) is amended— by striking paragraph
(2)and inserting the following: 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. In establishing the risk-based schedule under subparagraph (A), the Secretary shall— apply, to the extent applicable for device establishments, the factors identified in paragraph (4); and 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 in paragraph (4)— in the matter preceding subparagraph (A), by striking paragraph
(3)and inserting paragraph
(2)or
(3); and in subparagraph (C), by inserting or device after drug . 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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