21 C.F.R. § 801.119 In vitro diagnostic products.
Title 21 - Food and Drugs
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 section and section 502(f)(1) of the act if it meets the requirements of §809.10 of this chapter.
Title 21: Food and Drugs
PART 801—LABELING
Subpart D—Exemptions From Adequate Directions for Use
§ 801.119 In vitro diagnostic products.
