Laboratory Test Improvement Act
The source supplies the latest action, but no lifecycle stage.
Latest action (1 Mar 2007): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
What this bill does
The Laboratory Test Improvement Act, introduced in the Senate in 2007, would establish new regulations for laboratory-developed tests. These tests, which analyze biological specimens to report results, would be considered medical devices under federal law. The bill outlines requirements for manufacturers, including labeling with intended use and regulatory status, and registration of laboratories.
Manufacturers would need to submit information on the analytical and clinical validity of tests to the Secretary of Health and Human Services. This information would then be made available in a public database. The Secretary would also be required to issue guidance on using peer-reviewed literature and on when modifications to a test necessitate updated submissions. Additionally, the bill proposes creating a specialty area for certifying laboratories that conduct genetic testing using these methods, including proficiency testing standards.
As an introduced bill, S. 736 has not yet been passed by Congress. If enacted, it would amend the Federal Food, Drug, and Cosmetic Act to implement these new provisions regarding laboratory-developed tests, including direct-to-consumer tests, and would outline specific timelines for compliance and guidance issuance by the Secretary of Health and Human Services.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official 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.
Timeline
1 Mar 2007
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Common questions
- What does S. 736 do?
- The Laboratory Test Improvement Act, introduced in the Senate in 2007, would establish new regulations for laboratory-developed tests. These tests, which analyze biological specimens to report results, would be considered medical devices under federal law. The bill outlines requirements for manufacturers, including labeling with intended use and regulatory status, and registration of laboratories. Manufacturers would need to submit information on the analytical and clinical validity of tests to the Secretary of Health and Human Services. This information would then be made available in a public database. The Secretary would also be required to issue guidance on using peer-reviewed literature and on when modifications to a test necessitate updated submissions. Additionally, the bill proposes creating a specialty area for certifying laboratories that conduct genetic testing using these methods, including proficiency testing standards. As an introduced bill, S. 736 has not yet been passed by Congress. If enacted, it would amend the Federal Food, Drug, and Cosmetic Act to implement these new provisions regarding laboratory-developed tests, including direct-to-consumer tests, and would outline specific timelines for compliance and guidance issuance by the Secretary of Health and Human Services.
- Has S. 736 become law?
- The source does not supply a confirmed lifecycle stage for S. 736. Check the latest action and official source below.
- Who sponsored S. 736?
- S. 736 was sponsored by Sen. Kennedy, Edward M. [D-MA] (D-MA), with 1 cosponsor.
- What's the latest action on S. 736?
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (1 Mar 2007).
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