21 C.F.R. § 801.122
Medical devices for processing, repacking, or manufacturing.
Cite as 21 C.F.R. § 801.122 (2026)
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”.