Introduction to the Food and Drug Administration (FDA) regulatory process.

Abstract:

:FDA oversight of medical devices, including in vitro diagnostic devices (IVDs or laboratory tests), in the United States was a direct result of the passage of the Medical Device Amendments of 1976. This law introduced a series of general controls for medical devices including registration and listing, requirements for production using good manufacturing practices, and requirements for post-market reporting of device failures. This produced for the first time a menu of laboratory tests on the market, a system to ensure these were produced consistently over time, and a mechanism for FDA to identify problems with device use and to work with companies to ensure corrective action. This law also introduced the requirement for premarket review of new versions of old devices and of fundamentally new medical devices.

journal_name

J Proteome Res

authors

Hackett JL,Gutman SI

doi

10.1021/pr050059a

keywords:

subject

Has Abstract

pub_date

2005-07-01 00:00:00

pages

1110-3

issue

4

eissn

1535-3893

issn

1535-3907

journal_volume

4

pub_type

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