21 C.F.R. § 801.122 Medical devices for processing, repacking, or manufacturing.
Title 21 - Food and Drugs
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”.
Title 21: Food and Drugs
PART 801—LABELING
Subpart D—Exemptions From Adequate Directions for Use
§ 801.122 Medical devices for processing, repacking, or manufacturing.
