Update on FDA regulation of in vitro diagnostic devices.

doi:10.1001/JAMA.280.2.190

Paper

Update on FDA regulation of in vitro diagnostic devices.

Published Jul 8, 1998 · S. Gutman, K. Richter, S. Alpert

JAMA

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6

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1

Influential Citations

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Abstract

THE FOOD AND Drug Administration’s (FDA’s) authority for regulation of laboratory tests (in vitro diagnostic devices or IVDs) was established as a result of passage of the Medical Device Amendments of 1976. 1 Under this law, all medical devices (including IVDs) are subject to a variety of controls, including the requirement for manufacturers to register with the FDA and list their products, to comply with Current Good Manufacturing Practice, and to report serious device failures. This law provided the agency, for the first time in the late 1970s, with an inventory of tests already in the marketplace, tools to require that manufacturing practices be sound, and a system to ensure that serious problems are identified and remedied. In addition, the law put into place requirements for premarket review of medical devices entering the market for the first time.

Study Snapshot

The FDA's authority to regulate in vitro diagnostic devices (IVDs) was established in 1976 through the Medical Device Amendments of 1976, which require manufacturers to register with the FDA, comply with Current Good Manufacturing Practices, and report serious device failures.

PopulationOlder adults (50-71 years)

Sample size24

MethodsObservational

OutcomesBody Mass Index projections

ResultsSocial networks mitigate obesity in older groups.

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Paper

Update on FDA regulation of in vitro diagnostic devices.

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References

Citations

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