Regulation of Clinical Tests In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service

Language:

English

Subjects (All):

Genetics.

Laboratories.

Medical examinations.

Medical laws and legislation.

Physical Description:

1 online resource

Contained In:

ProQuest U.S. Congressional Research Digital Collection

Place of Publication:

[United States] [publisher not identified] 2014

Summary:

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

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

Notes:

CRS Report

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

Vendor supplied data

Other Format:

Microfiche version United Nations. Division for Social Policy and Development. Regulation of Clinical Tests

Publisher Number:

CRS-2014-DSP-0558

Access Restriction:

Restricted for use by site license