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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

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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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