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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers

 

BACKGROUND:

Questions have been raised as to whether an assembler of diagnostic X-ray systems must register as a device manufacturer.

POLICY:

Assemblers of diagnostic X-ray systems are subject to the assembler certification (reports of assembly) requirements in 21 CFR 1020.30(d) and the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C - Electronic Product Radiation Control.* Such assemblers are exempt from registration.

*Material between asterisks is new or revised*

Issued: 6/7/77

Reissued:10/1/80

Revised:9/24/87, 3/95