COMPLIANCE POLICY GUIDE (CPG)
CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers March 1995
- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Regulatory AffairsCenter for Devices and Radiological Health
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*
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:
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.