21 CFR Part 801 · Labeling

§ 801.122 Medical devices for processing, repacking, or manufacturing

Subpart D - Exemptions From Adequate Directions for Use Official text on eCFR Amendment history

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”.

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FDA guidance that cites § 801.122

Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA 30 Jul 2001

Amendment history

Federal Register documents that created or amended this section.

41 FR 6896 13 Feb 1976