Inspections, Compliance, Enforcement, and Criminal Investigations

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


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


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
Revised:9/24/87, 3/95

Page Last Updated: 03/20/2015
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