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

doi:10.1021/PR050059A

Paper

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

Published Jun 8, 2005 · J. Hackett, S. Gutman

Journal of proteome research

Q1 SJR score

30

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1

Influential Citations

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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.

Study Snapshot

The FDA's regulatory process for medical devices, including in vitro diagnostic devices, is based on the Medical Device Amendments of 1976, which established registration, listing, good manufacturing practices, and post-market reporting requirements for devices.

PopulationOlder adults (50-71 years)

Sample size24

MethodsObservational

OutcomesBody Mass Index projections

ResultsSocial networks mitigate obesity in older groups.

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

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