The FDA regulates IVD devices in accordance with the device provisions of the US Federal Food, Drug and Cosmetic Act (FDCA). Like other devices, IVDs are classified into one of three classifications that govern the types of regulation to which they are subject.
In Vitro Diagnostics (IVD)
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.
Class I, Class II, and Class III Regulatory Controls
The Code of Federal Regulations lists the classification of existing IVDs in 21 CFR 862, 21 CFR 864, and 21 CFR 866.
See also: Device Advice: Classify Your Medical Device
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 regulations 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