21 CFR § 801.122 Labeling

§ 801.122 Medical devices for processing, repacking, or manufacturing.

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

A device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the act if its label bears the statement “Caution: For manufacturing, processing, or repacking”.

← § 801.119 In vitro diagnostic products.§ 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. →