Regulation of Clinical Tests [electronic resource] : In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests
- Corporate Author:
- Library of Congress. Congressional Research Service
- [Place of publication not identified] : [publisher not identified], 2014.
- Physical Description:
- 1 online resource (25 pages), digital, PDF file
- Examines regulation of in vitro diagnostic devices by FDA through the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, as well as by CMS, through the Clinical Laboratory Improvement Amendments of 1988. Addresses oversight of laboratory developed tests and direct-to-consumer genetic testing. and This report is one in a series of updates. For the most recent coverage of this report series, please see 14-R4-3438 in the 2014 issue.
- Related Titles:
- ProQuest U.S. Congressional Research Digital Collection
- CRS Report. and Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Jan. 2014). Reuse except for individual research requires license from ProQuest, LLC.
- Technical Details:
- System requirements: PDF reader software.
View MARC record | catkey: 19199622