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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers March 1995

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Center for Devices and Radiological Health

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

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

 
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