In Vitro Diagnostic Product definition
In Vitro Diagnostic Product or "IVD" means a medical device as defined in section 210(h) of the FD&C Act, and may also be a biological product subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket clearance or approval by FDA as well as postmarket controls. Premarket clearance pursuant to the 510 (k) process applies to IVDs that are substantially equivalent to an existing predicate device and the premarket approval process applies to IVDs for which no predicate device exists. IVDs are also subject to the Clinical Laboratory Improvement Amendments of 1988. 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. [21 CFR 809.3]
In Vitro Diagnostic Product means a Licensed Product intended for use as an "in vitro diagnostic" (as defined in 21 CFR § 809.3) labeled in accordance with 21 CFR §§ 809.10.
In Vitro Diagnostic Product or “IVD” means a medical device as defined in section 210(h) of the FD&C Act, and may also be a biological product subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket clearance or approval by FDA, as well as, postmarket controls. Premarket clearance pursuant to the 510(k) process applies to IVDs that are substantially equivalent to an predicate device and the premarket approval