Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter H - MEDICAL DEVICESPart 801 - LABELING
Subpart D - EXEMPTIONS FROM ADEQUATE DIRECTIONS FOR USE
Section 801.122 - Medical devices for processing, repacking, or manufacturing

21 C.F.R. § 801.122

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Current through October 31, 2024
Section 801.122 - Medical devices for processing, repacking, or manufacturing

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 C.F.R. § 801.122