A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in § 809.3(a) of this chapter shall be deemed to be in compliance with the requirements of this part and section 502(f)(1) of the Federal Food, D
CFR 21-801.119-2013 history
2013CFR 21-801.119-2013 Food and Drugs. Part801:Labeling. Section801.119:In vitro diagnostic products.