21 CFR 801.122

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

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 801.122, § 801.122 Medical devices for processing, repacking, or manufacturing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88679
Permanent ID: ys:prov:88679@1
SHA-256: 287298b816c6d6d829c712ccfade65b2e6d72dc121c1fc479807ee06ca90e9b9

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Full text

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”.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.