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 .
21 CFR Part 801 · Labeling
§ 801.119 In vitro diagnostic products
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Warning letters citing § 801.119
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FDA guidance that cites § 801.119
Amendment history
Federal Register documents that created or amended this section.
- 78 FR 58820 24 Sept 2013