Regulatory aspects of IVDs

The US Food and Drug Administration (FDA) is involved in the regulation of IVDs or laboratory tests after the inception of the Medical Device Amendments of 1976. According to the guidelines of the FDA, IVD products are classified into Class I, II, or III which is based on the level of regulatory control that is essential to ensure the safety and effectiveness of devices. The Code of Federal Regulations lists the classification of existing IVDs in 21 CFR 862, 21 CFR 864, and 21 CFR 866. CLIA '88 is responsible for the quality standards of laboratory testing and an accreditation program for clinical laboratories. In the EU market, the In Vitro Diagnostics Directive (IVDD) 98/79/EC is the main regulatory requirements that medical device manufacturers comply with to get a CE marking in their products.