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*