Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers (CPG 7124.14)

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