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

Bill: 114-hr-2423
Sponsor: full_name: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-19
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Health technology, devices, supplies

Scientific communication
Latest action: action_date: 2015-05-22
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-05-19
action_desc: Introduced in House
text: <p>This bill amends the Federal Food, Drug, and Cosmetic Act to define &ldquo;valid scientific evidence&rdquo; to include well-documented case histories or studies published in peer-reviewed journals for purposes of the Food and Drug Administration (FDA) determining the effectiveness of a medical device without clinical investigation. Under specified conditions, the FDA may request the data underlying a study that is offered as valid scientific evidence.</p>

tv_txt: I 114th CONGRESS 1st Session H. R. 2423 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Shimkus introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to valid scientific evidence.

1. Valid scientific evidence Section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(a)(3)(B) ) is amended— (1) by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively; (2) by striking (B) If the Secretary and inserting (B)(i) If the Secretary ; and (3) by adding at the end the following: (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. .