Laboratory Test Improvement Act
Latest action · Mar 1, 2007 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 1, 2007
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 1
Members who signed on, in the order they did. All signed on Mar 1, 2007.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-OR | Gordon H. Smith | Original | Mar 1, 2007 |
Actions 3
Everything that happened, newest first.
- Mar 1, 2007Introduced in Senate
- Mar 1, 2007Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Mar 1, 2007Sponsor introductory remarks on measure. (CR S2502-2503)
Subjects
Assigned by the Library of Congress. Policy area: 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
- Health
- Internet
- Labeling
- Law
- Medical laboratories
- Medical supplies
- Medical tests
- Science, Technology, Communications
- Standards
- Tissue banks
- Web sites
Text 1
Each version as it was printed, newest first.
- Mar 1, 2007Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.