In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.
The Food and Drug Administration (FDA) has been involved in the regulation of in vitro diagnostic devices (IVDs or laboratory tests) since the introduction of the Medical Device Amendments of 1976. FDA classifies IVD products into Class I, II, or III according to the level of regulatory control that is necessary to assure safety and effectiveness. The classification of an IVD (or other medical device) determines the appropriate premarket process.
Please refer to the medical device module for some of the basic concepts involved in FDA regulation for medical devices in a sequence of the four medical device development stages. Further reguations and guidances for IVDs presented by the FDA can be found through the following links:
21 CFR part 809
In Vitro Diagnostics
Overview of IVD Regulation