21 CFR 801.122 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Labeling (§ 801.1 To § 801.437) — Exemptions From Adequate Directions For Use (§ 801.109 To § 801.128) — Medical devices for processing, repacking, or manufacturing.

4 Aug 2016

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”.

21 CFR 801.122