what is an ivd
Definition: 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.t allows the recipient of an NSE (not substantially equivalent) letter to request a risk-based classification determination to be made for the device. In some cases, this allows a manufacturer to use the De Novo process to submit a 510(k) for a new IVD that would otherwise have to get to market via the PMA process.