§263a. Certification of laboratories — Inbound Citations
42 U.S.C. § 263a
Cited by 11 provisions in release 119-102.
Citations to 42 U.S.C. § 263a as a whole
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(4) the term “laboratory” has the meaning given the term in section 353 of the Public Health Service Act (42 U.S.C. 263a); and
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(1) In issuing an authorization under this section with respect to a device, the Secretary may, subject to the provisions of this section, determine that a laboratory examination or procedure associated with such device shall be deemed, for purposes of section 353 of the Public Health Service Act [42 U.S.C. 263a], to be in a particular category of examinations and procedures (including the category described by subsection (d)(3) of such section) if, based on the totality of scientific evidence available to the Secretary—(A) such categorization would be beneficial to protecting the public health; and(B) the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization.
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(3) A determination under this subsection shall be effective for purposes of section 353 of the Public Health Service Act [42 U.S.C. 263a] notwithstanding any other provision of that section during the effective period of the relevant declaration under subsection (b).
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(2) The certification program shall provide for the submission of an application to a State by an embryo laboratory for certification, in such form as may be specified by the State. Such an application shall include—(A) assurances satisfactory to the State that the embryo laboratory will be operated in accordance with the standards under subsection (d),(B) a report to the State identifying the assisted reproductive technology programs with which the laboratory is associated, and(C) such other information as the State finds necessary.An embryo laboratory which meets the requirements of section 263a of this title shall, for the purposes of subparagraph (A) be considered in compliance with the standards referred to in such subparagraph which are the same as the standards in effect under section 263a of this title.
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(4) The Director of the Program shall, through the plan issued under section 300aa–3 of this title, coordinate and provide direction for the allocation of resources in the implementation of the licensing program under section 263a of this title.
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(e) Notwithstanding any other provision of law, the Secretary may not impose, or require a State to impose, any fee on any facility or entity subject to a determination under subsection (a), or any renal dialysis facility subject to the requirements of section 1395rr(b)(1) of this title, for any such determination or any survey relating to determining the compliance of such facility or entity with any requirement of this subchapter (other than any fee relating to section 263a of this title).
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(A) meets the certification requirements under section 353 of the Public Health Service Act [42 U.S.C. 263a]; and
Citations to §263a(a)
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(10) The term “laboratory” has the meaning given such term in section 263a(a) of this title.
Citations to §263a(d)(3)
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(1) In issuing an authorization under this section with respect to a device, the Secretary may, subject to the provisions of this section, determine that a laboratory examination or procedure associated with such device shall be deemed, for purposes of section 353 of the Public Health Service Act [42 U.S.C. 263a], to be in a particular category of examinations and procedures (including the category described by subsection (d)(3) of such section) if, based on the totality of scientific evidence available to the Secretary—(A) such categorization would be beneficial to protecting the public health; and(B) the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization.
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(k) For a device authorized for emergency use under section 360bbb–3 of this title for which, in accordance with section 360bbb–3(m) of this title, the Secretary has deemed a laboratory examination or procedure associated with such device to be in the category of examinations and procedures described in section 263a(d)(3) of title 42, the sponsor of such device may, when submitting a request for classification under subsection (f)(2), submit a single submission containing—(1) the information needed for such a request; and(2) sufficient information to enable the Secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized under section 263a(d)(3) of title 42.
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(2) sufficient information to enable the Secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized under section 263a(d)(3) of title 42.