Sec. 2222. Valid scientific evidence
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/bill/114/hr/6/eh/section-2222A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(a)(3)(B) ) is amended— by redesignating clauses
(i)and
(ii)as subclauses
(I)and (II), respectively; by striking
(B)If the Secretary and inserting (B)(i) If the Secretary ; and by adding at the end the following: For purposes of clause (i), valid scientific evidence may include— evidence described in well-documented case histories, including registry data, that are collected and monitored under a protocol determined to be acceptable by the Secretary; studies published in peer-reviewed journals; and data collected in countries other than the United States so long as such data otherwise meet the criteria specified in this subparagraph. In the case of a study published in a peer-reviewed journal that is offered as valid scientific evidence for purposes of clause (i), the Secretary may request data underlying the study if— the Secretary, in making such request, complies with the requirement of subparagraph (D)(ii) to consider the least burdensome appropriate means of evaluating device effectiveness or subsection (i)(1)(D) to consider the least burdensome means of determining substantial equivalence, as applicable; the Secretary furnishes a written rationale for so requesting the underlying data together with such request; and if the requested underlying data for such a study are unavailable, the Secretary shall consider such study to be part of the totality of the evidence with respect to the device, as the Secretary determines appropriate. .
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Sec. 2222
Valid scientific evidence
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