21 CFR § 801.119 Labeling

§ 801.119 In vitro diagnostic products.

Current through Sep 8, 2026 · Read all of Part 801

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, Drug, and Cosmetic Act if it meets the requirements of subpart B of this part and the requirements of § 809.10 of this chapter.

[78 FR 58820, Sept. 24, 2013]

← § 801.116 Medical devices having commonly known directions.§ 801.122 Medical devices for processing, repacking, or manufacturing. →