3.0.0 3005 2023-01-11T13:24:17Z 2023-01-11T13:24:17Z House H HR 2013-08-02 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. BURGESS:H.R. 3005.Congress has the power to enact this legislation pursuantto the following:The attached bill is constitutional under Article I,Section VIII: ``The Congress shall have Power To regulateCommerce with foreign Nations, and among the severalStates.''[[Page H5401]][Page H5400]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-08-02T14:22:41Z Referred to 2013-08-02T13:08:05Z 2013-08-02 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-08-02 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-08-02 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-08-02 Introduced in House IntroReferral 1000 9 Library of Congress B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 N S001175 Rep. Speier, Jackie [D-CA-14] Jackie Speier D CA 14 2013-08-02 True H001034 Rep. Honda, Michael M. [D-CA-17] MICHAEL HONDA D CA M. 17 2013-09-10 False E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 2013-09-18 False H001038 Rep. Higgins, Brian [D-NY-26] Brian Higgins D NY 26 2013-09-26 False G000377 Rep. Granger, Kay [R-TX-12] KAY GRANGER R TX 12 2013-09-26 False B001285 Rep. Brownley, Julia [D-CA-26] Julia Brownley D CA 26 2013-10-07 False P000608 Rep. Peters, Scott H. [D-CA-52] Scott Peters D CA H. 52 2013-11-18 False Health Consumer affairs Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Medical research Product safety and quality Health 00 2013-08-02 Introduced in House 2013-12-06T20:05:58Z Medical Testing Availability Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to labeling in the shipment or delivery of an in vitro diagnostic product for an investigation exempt from compliance with a performance standard or the requirement of premarket approval.

Declares that such a product whose labeling states "For Research Use Only. Not for use in diagnostic procedures." may not be deemed misbranded on the basis that its manufacturer or distributor: (1) sells the product to an end user who uses the product in a manner inconsistent with such statement, or (2) engages in business communications regarding the product with an end user.

Defines "business communications": (1) as oral, written, or electronic contact between a manufacturer or distributor of such a product and an end user regarding the product's functioning; and (2) includes any such contact consisting of technical support, customer service, assistance with the installation of such product, communication relating to ensuring the performance of the product, and other similar contacts.

]]> Medical Testing Availability Act of 2013 Display Title Medical Testing Availability Act of 2013 Official Title as Introduced To amend chapter V of the Federal Food, Drug, and Cosmetic Act to permit the sale of, and access to, "research use only" products in diagnostic tests. Introduced in House IH Short Titles as Introduced Medical Testing Availability Act of 2013 Introduced in House 2013-08-02T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr3005ih/xml/BILLS-113hr3005ih.xml 2013-08-02 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.