To amend the Federal Food, Drug, and Cosmetic Act with respect to valid scientific evidence.

“(ii) Valid scientific evidence for purposes of clause (i) may include:

“(I) evidence described in well-documented case histories, including registry data, that are collected and monitored under an acceptable protocol;

“(II) studies published in peer-reviewed journals; and

“(III) data collected in countries other than the United States so long as such data otherwise meets the criteria specified in this subparagraph.

“(iii) 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—

“(I) 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;

“(II) the Secretary furnishes a written rationale for so requesting the underlying data together with such request; and

“(III) 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.”