3.0.0 736 2023-01-11T19:47:00Z 2023-01-11T19:47:00Z Senate S S 2007-03-01 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2007-03-01T23:09:20Z 2007-03-01 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2007-03-01 Sponsor introductory remarks on measure. (CR S2502-2503) IntroReferral B00100 9 Library of Congress 2007-03-01 Introduced in Senate IntroReferral 10000 9 Library of Congress K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE N S001142 Sen. Smith, Gordon H. [R-OR] GORDON SMITH R OR H. 2007-03-01 True Health Administrative procedure Commerce Data banks Department of Health and Human Services Electronic data interchange Food and Drug Administration (FDA) Genetics Government Operations and Politics Government paperwork Government publicity Internet Labeling Law Medical laboratories Medical supplies Medical tests Science, Technology, Communications Standards Tissue banks Web sites Health 00 2007-03-01 Introduced in Senate 2007-05-07T15:29:31Z Laboratory Test Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a laboratory-developed test that is a direct-to-consumer test to be a prescription test if it satisfies the requirements of this Act.

Deems any laboratory-developed test to be a medical device.

Sets forth labeling and registration requirements for laboratory-developed tests.

Requires the manufacturer of a laboratory-developed test that has not been cleared or approved for its intended use to submit the analytical and clinical validity of the test for its intended use to the Secretary of Health and Human Services. Requires the Secretary to include such information in a public database.

Requires the Secretary to provide guidance to: (1) facilitate the use of reviews of the peer-reviewed biomedical literature and other information and data about the clinical validity of laboratory-developed tests and in vitro diagnostic products when clearing or approving such tests and products under the FFDCA; and (2) clarify when modifications to a laboratory-developed test require updating of the submitted information.

Sets forth provisions regarding classification of laboratory-developed tests.

Requires the Secretary to issue a proposed rule to establish a specialty area for the certification of laboratories for laboratory-developed tests to acquire genetic information, which shall include standards for proficiency testing of such tests.

]]> Laboratory Test Improvement Act Official Title as Introduced A bill to provide for the regulation and oversight of laboratory tests. Introduced in Senate IS Display Title Laboratory Test Improvement Act Short Titles as Introduced Laboratory Test Improvement Act Introduced in Senate 2007-03-01T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s736is/xml/BILLS-110s736is.xml 2007-03-01 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.