Franklin

Regulation of Clinical Tests [electronic resource] : In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests.

Author/Creator:
Library of Congress. Congressional Research Service.
Publication:
[S.l] : [s.n.], 2014.
Format/Description:
Government document
Book
1 online resource (1 online resource (22 p), digital, PDF file)
Subjects:
Genetics.
Laboratories.
Medical laws and legislation.
Medicine -- Research.
Summary:
Provides overview of regulation of in vitro diagnostic (IVD) devices by FDA through the Federal Food, Drug, and Cosmetics Act (FFDCA) and the Public Health Service Act (PHSA), as well as by CMS, through the Clinical Laboratory Improvement Amendments (CLIA) of 1988. Addresses issues for Congress, including oversight of laboratory developed tests, oversight of direct-to-consumer genetic testing, and FDA approval or clearance and Medicare national coverage determinations.
Notes:
Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed May 2014). Reuse except for individual research requires license from ProQuest, LLC.
CRS Report.
Other format:
Microfiche version: Library of Congress. Congressional Research Service. Regulation of Clinical Tests
Access Restriction:
Restricted for use by site license.
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